Health Technology Review

Nabilone for Behavioural and Psychological Symptoms of Dementia

Main Take-Away

• Nabilone, a synthetic cannabinoid, may be an effective treatment for agitation in some patients with Alzheimer disease, based on 1 small trial. However, the evidence is uncertain, and it is unclear whether the effects of nabilone are meaningful to patients.

Key Messages

What Is the Issue?

• Nabilone may have neuroprotective effects that could reduce the behavioural and psychological symptoms of dementia (BPSD).

• Decision-makers are interested in understanding whether nabilone could be used as a potential alternative to antipsychotics for the treatment of BPSD in people with dementia.

What Did We Do?

• We conducted a focused literature search and issued a targeted call for input from interested parties to inform our understanding of the current treatment landscape for BPSD, interpretation of the literature, and outcomes that are important to patients and clinicians.

• We engaged 2 clinical experts in the management and treatment of certain health conditions in older adults to provide input on the project protocol and peer review the draft report.

What Did We Find?

• A small placebo-controlled trial, in which patients with moderate-to-severe Alzheimer disease received both nabilone and placebo at different times, showed that compared to placebo, nabilone:

  • moderately decreased agitation; however, it is unclear whether this effect is meaningful to patients

  • improved neuropsychiatric symptoms and overall behavioural symptoms; however, the clinical meaningfulness of this is unknown

  • resulted in small improvements in cognition, nutritional status, and caregiver burden, though the clinical meaningfulness of these observations remains to be determined

  • resulted in a higher clinically meaningful frequency of sedation.

• We found an evidence-based guideline that suggests that synthetic cannabinoids, including nabilone, may be used for severe agitation in people living with Alzheimer disease or related dementia if other pharmacological treatments have been unsuccessful.

• We did not find any studies on the cost-effectiveness of nabilone or data on potential cost offsets associated with nabilone use in long-term care settings.

What Does This Mean?

• The effects of nabilone on agitation in patients with moderate-to-severe Alzheimer disease were moderate, and it is unclear whether this improvement is meaningful to patients.

• Evidence from larger studies with robust methodology and a longer follow-up period is needed to validate these observations.

Context and Policy Issues

What Are Dementia and Behavioural and Psychological Symptoms of Dementia?

In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, dementia is formally classified as a major neurocognitive disorder that is characterized by a decline in cognition (e.g., memory, executive function, language) and loss of function (e.g., ability to perform daily tasks).¹ Many diseases, injuries, and conditions that affect different parts of the brain can cause dementia, with Alzheimer disease being the most common cause, accounting for up to 70% of cases.² The other types of dementia include vascular dementia, Lewy body disease, mixed dementia, frontotemporal dementia, Parkinson disease, and Korsakoff dementia, among others.³

Between April 2022 and March 2023 in Canada, approximately 99,000 people aged 65 and older were newly diagnosed with dementia, and 487,000 people aged 65 and older were living with diagnosed dementia.⁴ The number of people living with dementia in Canada may be higher if it also includes those who have not been formally diagnosed by a health care provider.⁴ Approximately 3% of all people living with dementia are younger than 65 years.⁴

Behavioural and psychological symptoms of dementia (BPSD), also known as responsive behaviours, are noncognitive, neuropsychiatric, and behavioural disturbances.⁵ In Canada, BPSD affects up to 75% of community-dwelling people living with dementia⁶ and more than 80% of people living with dementia who reside in long-term care facilities.⁷ Common symptoms of BPSD include agitation, aggression, mood disorders (e.g., depression, apathy, anxiety), psychosis (e.g., hallucinations, delusions), sleep disturbances, and changes in appetite.^6,8 These symptoms are more frequent and worsen as dementia progresses, and are associated with poor mental health outcomes and decreased quality of life for people living with dementia as well as caregivers.⁸

What Are the Treatment Options for BPSD?

BPSD is usually managed by nonpharmacological and pharmacological interventions to improve the symptoms and quality of life.⁵ Nonpharmacological interventions include sensory and cognitive stimulation, psychological approaches, environmental modifications, and caregiver education.⁹ Pharmacological interventions sometimes used for BPSD can include antipsychotic agents, antidepressants, sedative and hypnotic agents, mood stabilizers, and cholinesterase inhibitors, although the evidence for many of these medications is limited outside of specific situations.¹⁰

First-line treatment of BPSD involves a range of non-pharmacological interventions, which have limited adverse effects, and are more effective than pharmacological interventions for managing less severe symptoms.^5,10 Pharmacological interventions may be required to manage more severe symptoms, particularly for agitation, or when nonpharmacological interventions have been unsuccessful.¹⁰

Despite their moderate efficacy in improving BPSD, the side effects of antipsychotics are substantial, including excessive sedation, orthostatic hypotension (increasing the risk of falls), and cerebrovascular accidents (increasing the risk of stroke and death).¹⁰

Why Is It Important to Do This Review?

There is an unmet need to find an alternative therapy that is as effective as antipsychotics but with less severe side effects for specific BPSD such as agitation. More recently, cannabinoids have been investigated for the treatment of multiple medical conditions, including chronic pain and psychiatric disorders.¹¹

Cannabinoids consist of 3 general classes, including herbal cannabinoids (from the cannabis plant), endogenous cannabinoids (produced in the bodies of humans and animals), and synthetic cannabinoids (e.g., dronabinol, nabilone).¹² In Canada, nabilone is approved for the treatment of severe nausea and vomiting associated with cancer chemotherapy due to its antiemetic properties.¹³ However, a recent database study showed that prescriptions of nabilone for long-term care residents in Canada increased following the legalization of recreational cannabis. Most of the nabilone prescriptions were off-label, particularly for non–cancer-related pain, depression, or anxiety disorders.¹⁴

As potential treatments for dementia, the safety and efficacy of cannabinoids in the management of BPSD have been investigated in preclinical studies and in several small clinical trials.¹² Although findings from preclinical studies were promising for BPSD-like behaviours, such as agitation, aggression, and apathy, the findings from the clinical studies were mixed due to small sample size, lack of an adequate control, short trial duration, and low quality, which limit the ability to draw informed, evidence-based conclusions.¹²

With the need to identify alternative treatment options for BPSD, such as agitation, that may reduce health care-related costs associated with antipsychotic drug use in long-term care settings, a review of the efficacy, safety, and cost-effectiveness of nabilone was undertaken to help inform decision-makers. In addition, this review also aimed to identify recommendations from evidence-based guidelines regarding the use of nabilone for the treatment of BPSD.

Research Questions

1. What is the clinical efficacy and safety of nabilone compared with pharmacological treatments, nonpharmacological treatments, or no treatment for patients with specific BPSD?

2. What is the cost-effectiveness of nabilone compared with pharmacological treatments, nonpharmacological treatments, or no treatment for patients with BPSD?

3. What are the evidence-based guideline recommendations on the use of nabilone for the treatment of patients with BPSD?

Methods

Literature Search Methods

An information specialist conducted a literature search on key resources including MEDLINE, Embase, PsycINFO, the Cochrane Database of Systematic Reviews, the International HTA Database, the websites of health technology assessment agencies in Canada and major international HTA agencies, as well as a focused internet search. The search approach was customized to retrieve a limited set of results, balancing comprehensiveness with relevance. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. Search concepts were developed based on the elements of the research questions and selection criteria. The main search concepts were nabilone and dementia. An additional search was conducted using the search concepts dementia and behavioural and psychological symptoms; search filters were applied to this search to limit retrieval to guidelines. Conference abstracts and clinical trial registry records were excluded from both searches. The searches were completed on March 2, 2026, and were limited to English-language documents published since January 1, 2016. The search strategies are available on request.

Selection Criteria and Methods

Two reviewers independently selected relevant studies for inclusion in 2 stages, first by titles and abstracts and then by full texts based on the inclusion criteria presented in Table 1. Any record considered relevant by either reviewer at the title and abstract stage was reviewed by full text. Both reviewers agreed on the studies included in the report.

Table 1: Selection Criteria

AE = adverse event; BPSD = behavioural and psychological symptoms of dementia; MA = meta-analysis; NMA = network meta-analysis; NPI = Neuropsychiatric Inventory; PICO = population, intervention, comparison, and outcome; QALY = quality-adjusted life-year; RCT = randomized controlled trial.

^aThis review employed a hierarchical approach to evidence inclusion, prioritizing the most robust and current evidence. We first sought recent, comprehensive, and high-quality systematic reviews, MAs, or NMAs. If we did not identify suitable systematic reviews for the PICO question, or if supplementation is needed, we included RCTs.

^bA guideline is considered evidence-based if a systematic search of the literature was undertaken and a guideline panel was involved in informing the recommendations.

Exclusion Criteria

Articles were excluded if they did not meet the selection criteria outlined in Table 1 or if they were published before 2016. Systematic reviews were excluded if the included studies evaluating natural cannabinoids and synthetic cannabinoids were combined in a meta-analysis. Guidelines with unclear methodology were also excluded.

Critical Appraisal of Individual Studies

The included publications were critically appraised by 1 reviewer and checked by a second reviewer using the following tools as a guide: the revised Cochrane Risk of Bias Tool for Randomized Controlled Trials (RoB 2)¹⁵ and the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument¹⁶ for guidelines. Summary scores were not calculated for the included studies; rather, the strengths and limitations of each included publication were described narratively.

Engagement

A call for input on the project protocol from interested parties was issued at project initiation through the Canada’s Drug Agency weekly newsletter and on our website. Patient and clinician groups with whom we have previously engaged were proactively notified of the opportunity to provide input. Two clinicians from Western and Central Canada with expertise in geriatric psychiatry provided input on the project scope. Their input provided important contextual insights that helped inform the research team’s understanding of the current treatment landscape, unmet needs, priority outcomes, search strategy, and interpretation of evidence. The clinicians highlighted ongoing challenges in the management of BPSD, noting that many affected patients reside in long-term care settings, where care needs are often complex. Key issues raised included limitations associated with current treatment options in terms of efficacy and safety, and workforce constraints that impact the ability to deliver care. Collectively, the input highlighted that there may be a need for additional therapeutic options that are feasible to implement in long-term care settings across Canada. It was also noted that there is an ongoing phase III clinical trial evaluating nabilone for the treatment of agitation in patients with Alzheimer disease (NCT04516057).

Clinical Expert Engagement

Two clinical experts with expertise in the management and treatment of certain health conditions in older adults, as well as the appropriate use of drugs in this population, were consulted during the review. Both experts provided input on the project protocol, including the proposed scope and refinement of the review. The experts also reviewed and provided feedback on the draft report, offering clinical context and interpretation of the evidence. Their input was used to help inform the interpretation of findings and the identification of key limitations and considerations for future research.

Summary of Evidence

Quantity of Research Available

A total of 189 citations were identified in the literature search. Following screening of titles and abstracts, 176 citations were excluded, and 13 potentially relevant reports from the electronic search were retrieved for full-text review. One potentially relevant publication was retrieved from the grey literature search for full-text review. Of these potentially relevant articles, 12 publications were excluded for various reasons, and 2 publications met the inclusion criteria and were included in this report. These included 1 randomized controlled trial (RCT) and 1 evidence-based guideline. Appendix 1 presents the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA)¹⁷ flow chart of the study selection. The lists of included studies (Table 2) and excluded studies (Table 3), with the inputs from the clinical experts, are provided in Appendix 2.

Summary of Study Characteristics

Appendix 3 provides details regarding the characteristics of the included primary study (Table 4) and the included evidence-based guideline (Table 5).

Included Studies for Research Question 1: What Is the Clinical Efficacy and Safety of Nabilone Compared With Pharmacological Treatments, Nonpharmacological Treatments, or No Treatment for Patients With BPSD?

Study Design

The included primary study was a randomized, placebo-controlled, double-blind crossover trial.

Country of Origin

The crossover RCT by Herrmann et al. (2019)¹⁸ was conducted by authors in Canada.

Patient Population

Patients in the RCT by Herrmann et al. (2019)¹⁸ were adults with moderate-to-severe Alzheimer disease, who had a score of less than or equal to 24 on the Standardized Mini-Mental State Examination (SMMSE) and clinically substantial agitation/aggression (Neuropsychiatric Inventory–Nursing Home version [NPI-NH]-agitation/aggression subscore ≥ 3). All but 1 participant (97%) met the International Psychogeriatric Association (IPA) research diagnostic criteria for agitation. The mean age of participants was 87 years, with fewer female (23%) than male (77%) participants. Most of the participants were patients from the Sunnybrook Health Sciences Centre long-term care facility (72%), whereas the remaining were outpatients (18%) from geriatric psychiatry clinics across the Greater Toronto Area.

Patients had to be on a stable dose of a cognitive enhancer (cholinesterase inhibitors or memantine) for 3 months or more and psychotropics for more than 1 month before randomization. Patients were excluded if they had contraindications to nabilone, unstable cardiovascular disease, or the presence or history of other neurologic conditions or other psychiatric disorders, including delusions or hallucinations.

Interventions and Comparators

The crossover RCT by Herrmann et al. (2019)¹⁸ compared the efficacy and safety of nabilone versus placebo in patients living in long-term care settings and outpatients with moderate-to-severe Alzheimer disease and agitation. The study was a 14-week crossover trial that compared nabilone (1 mg to 2 mg per day) to placebo (6 weeks each) with a 1-week washout between phases. During the nabilone phase, participants initially received 0.25 mg/day, which was slowly titrated up to a maximum target dose of 2 mg/day. In case of an intolerable adverse event (AE) potentially related to the study medication, the dose was decreased by 0.5 mg increments until resolution. The study medication was discontinued if side effects were still intolerable at 1 mg/day. The maintenance dose was down-titrated at week 6 to reduce the risk of potential withdrawal. The same dosing structure was applied during the placebo phase. The mean tolerated dose of nabilone per day was 1.6 mg (± 0.5 mg).

Outcomes

The efficacy outcomes in the crossover RCT by Herrmann et al. (2019)¹⁸ were agitation assessed by the Cohen-Mansfield Agitation Inventory (CMAI); cognition assessed by the SMMSE, the Severe Impairment Battery (SIB), and the Alzheimer Disease Assessment Scale–Cognitive Subscale (ADAS-Cog); neuropsychiatric symptoms assessed by the NPI-NH; caregiver burden assessed by the NPI-NH caregiver distress score; behaviour assessed by taking the sum of 3 CMAI subscales (CMAI-IPA score) (physical aggression, verbal aggression, and physical nonaggression) and the Clinical Global Impression of Change (CGIC); nutritional status assessed by the Mini Nutritional Assessment Short-Form (MNA-SF), weight, and body mass index (BMI); and pain assessed by the Pain Assessment in Advanced Dementia (PAINAD).

Brief descriptions of the efficacy outcome measures are as follows:

• CMAI: a 29-item scale that measures 4 domains of agitation — physical/aggressive (questions 1 to 11), physical/nonaggressive (questions 12 to 21), verbal/aggressive (questions 22 to 24), and verbal nonaggressive (questions 25 to 29).¹⁹ Each item is rated on a scale from 1 (never) to 7 (several times an hour). The overall CMAI total score (29 items) ranges from 29 to 203, with higher scores indicating greater agitation severity. The minimal important difference (MID) for CMAI total score ranges from –4 points (up to a month) to –11 points (more than 1 to 3 months).²⁰

• SMMSE: an 11-question measure that tests 5 areas of cognitive function — orientation, registration, attention and calculation, recall, and language.²¹ The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The MID for SMMSE is 1.4 points.²²

• SIB: used to assess cognition in patients with SMMSE less than or equal to 15.²³ The SIB contains 6 major subscales to assess mild-to-moderate dementia: attention, orientation, language, memory, visuospatial ability, and construction. All but 2 of the SIB items are scored on a 3-point scale: 2 = correct; 1 = partially correct, and appropriate or closely related answer; and 0 = incorrect. The other 2 questions only have a 0 or a 1 point answer. Lower scores indicate greater impairment. Specific numerical MID for SIB is not available.

• ADAS-Cog: an 11-task neuropsychological assessment (0 to 70 scale) measuring dementia severity, memory, language, and praxis (motor tasks).²⁴ Higher scores indicate greater impairment. The MID for ADAS-Cog is 2 points.²⁵

• NPI-NH: a carer-based tool that assesses the possible presence of 12 symptoms in dementia cases, including delusions, hallucinations, apathy, depression, agitation, euphoria, aberrant motor behaviour, irritability, disinhibition, anxiety, sleeping, and eating.²⁶ The greater the score, the more severe and frequent the behavioural disturbances. The MID for NPI-NH severity ranges from –3.2 to –2.8 points.²⁷

• NPI-NH caregiver distress score: a tool that measures the emotional burden and work disruption of caregiver caused by dementia-related behaviours by using a 6-point scale (0 to 5) per symptom listed in NPI-NH (e.g., agitation, delusions, or apathy) with 0 being “not at all” and 5 being “extremely” distressing.²⁸ Higher scores indicate higher levels of stress and burden on caregiver. The MID for NPI-NH caregiver distress ranges from –3.95 to –3.10 points.²⁷

• CMAI-IPA: derived from the 29-item questionnaire of CMAI by selecting items that align with the 3 main IPA Provisional Research Criteria for Agitation (i.e., physical aggression, verbal aggression, and physical nonaggression/restlessness).²⁹ Higher scores indicate more severe, frequent agitation. The MID for CMAI-IPA ranges from –2 (at 1 month) to –5 (at 3 months) points.³⁰

• CGI: a 3-item clinician-rated assessment tool that measures psychiatric illness severity (CGI-S), global improvement (CGI-I) and efficacy (CGI-E).³¹ The scale is often used as an anchor to define the MID for other instruments (such as the CMAI, rather than having a single fixed MID value itself). CGI-S rates the current state of the illness from 1 (normal, not at all ill) to 7 (among the most extremely ill). CGI-I rates the change in the patient's condition compared to baseline, ranging from 1 (very much improved) to 7 (very much worse).CGI-E is an efficacy index integrating the treatment effect with its side effects on a 4-point matrix (ranging from no side effects to significant side effects that outweigh the treatment benefits.

• CGIC: a 7-point scale used in clinical trials and practice to measure a patient’s improvement or decline after treatment. It assesses the overall effectiveness of the treatment, typically ranging from "very much improved" to "very much worse." Usually, the scale is 1 to 7 — 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change, 5) Minimally worse, 6) Much worse, 7) Very much worse.

• MNA-SF: a screening tool used to categorize patients as malnourished or at risk of malnutrition. It contains 6 questions (maximum 14 points) assessing recent changes in appetite, weight loss, mobility, psychological stress/acute disease, current neuropsychological problems, and BMI.³² A score of 11 or less is considered a threshold that requires assessment and intervention.³³ A specific numerical MID for MNA-SF is not available. A score of 12 to 14 points indicates normal nutritional status, a score of 8 to 11 points indicates that the patient is at risk of malnutrition, and a score of 0 to 7 points indicates that the patient is malnourished.

• PAINAD: a tool used to evaluate pain in individuals with dementia or cognitive impairment who cannot verbally communicate their pain. It assesses 5 behaviours: breathing, negative vocalization, facial expression, body language, and consolability, with total scores ranging from 0 (no pain) to 10 (severe pain).³⁴ A score of 2 or more is considered a threshold for indicating “probable pain.”³⁵

Safety outcomes reported in the included RCT¹⁸ were treatment-emergent AEs (TEAEs) and serious adverse events (SAEs).

Included Studies for Research Question 2: What Is the Cost-Effectiveness of Nabilone Compared With Pharmacological Treatments, Nonpharmacological Treatments, or No Treatment for Patients With BPSD?

We did not identify any economic evaluation studies on the cost-effectiveness of nabilone compared with pharmacological treatments, non-pharmacological treatments, or no treatment for patients with BPSD.

Included Studies for Research Question 3: What Are the Evidence-Based Guideline Recommendations on the Use of Nabilone for the Treatment of Patients With BPSD?

Study Design

The Canadian Coalition for Seniors’ Mental Health (CCSMH)^36,37 developed an evidence-based clinical practice guideline to provide good practice statements and recommendations on assessing and managing specific BPSD among people living with dementia. The guideline development group consisted of 15 members and included representatives from geriatric psychiatry, geriatric medicine, family medicine, pharmacy, psychology, neurology, nursing, and pharmacology. Guideline panel members were involved in the development of topics and in reviewing the evidence by conducting a systematic review of existing guidelines on BPSD, a rapid overview of systematic reviews on BPSD assessment and management, and a rapid review of nonpharmacological and pharmacological interventions. The quality of evidence was rated per GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology as very low, low, moderate, or high. Each recommendation was rated as either strong or conditional, based on the level of evidence and the confidence that the benefits of each recommendation outweighed the risks.

Country of Origin

The authors of the CCSMH guideline^36,37 were from Canada.

Target Population and Intended Users

The patient population of the CCSMH guideline^36,37 was people with lived experience of dementia. The guideline may be applied in community, outpatient, inpatient, and long-term care and other residential care settings.

The intended users of the guideline include health care providers, people living with dementia, and caregivers of people living with dementia.

Interventions and Practice Considered

The CCSMH guideline^36,37 provides guidance on assessing and managing BPSD in the care of people living with dementia within a Canadian context, using nonpharmacological and pharmacological approaches.

Outcomes

The CCSMH guideline^36,37 considered all relevant outcomes related to the clinical effectiveness, health-related quality of life, and safety of nonpharmacological and pharmacological interventions.

Summary of Critical Appraisal

Randomized Controlled Trial

Table 6 of Appendix 4 presents the risk of bias assessment of the included RCT by Herrmann et al. (2019)¹⁸ using the RoB 2 tool.¹⁵

Internal Validity

Randomization was conducted using a block randomization code that was independently computer-generated by the institutional pharmacy department. The methods of randomization and allocation concealment were reported. There were no imbalances in patient baseline characteristics because all participants received the first treatment (nabilone) for 6 weeks, followed by a 1-week washout, then crossed over to a second treatment (placebo) for another 6 weeks. The 1-week washout period appeared to be sufficient to clear any carryover effects, given that the plasma half-life values for nabilone and its metabolites are approximately 2 and 35 hours, respectively.

Of the 38 patients who underwent treatment with nabilone in the first phase, 5 terminated treatment early due to a SAE. Of the remaining 33 patients who then underwent treatment with placebo in the second phase, 4 patients terminated treatment early due to an SAE. Thus, it appears that the number of participants who underwent each treatment was not equal. However, data from all participants were included in the analyses, and paired data from all participants were used without imputation. All prespecified outcomes were analyzed using the intention-to-treat population, meaning that all patients who were randomized to receive at least 1 dose of the study medication and completed at least 1 nonbaseline questionnaire were included.

The study reported that patients, family members, nurses, clinicians, outcome assessors, and investigators were blinded to treatment allocation and block size. However, clinicians and outcome assessors could be considered unblinded due to the specific AE of nabilone (i.e., sedation).

Methods of measuring the outcomes were appropriate, similar between intervention groups, and clearly described in the published protocol³⁸ of the trial and in ClinicalTrials.gov (NCT02351882). The data were analyzed in accordance with a prespecified plan, and therefore, the results being assessed were unlikely to have been selected. However, measurement of outcomes could have been influenced by the knowledge of the intervention due to the presence of the specific AE of nabilone (i.e., sedation).

There was no adjustment for multiple testing of the secondary outcomes, which means that there is a higher probability of statistical significance by chance alone, increasing the risk a false-positive result (type I error).

Overall, the study had a low risk of bias in terms of the randomization process, carryover effects, missing outcome data, and selection of the reported results. However, the study might have a high risk of bias in the measurement of outcomes and had some limitations in the statistical analyses.

External Validity

The inclusion and exclusion criteria of the study limit the ability to generalize the findings to all patients with dementia in Canada. Participants in this study were mostly male, limiting its generalizability to female patients with dementia. Patients were recruited from a single centre (i.e., Sunnybrook Health Sciences Centre long-term care facility) and outpatient geriatric psychiatry clinics across the Greater Toronto Area, which may limit broad generalization of the results to patients across Canada.

Guideline

Table 7 of Appendix 4 presents the strengths and limitations of the included guideline.^36,37

The CCSMH guideline^36,37 had several strengths related to reporting. It was explicit in terms of scope and purpose (i.e., objectives, health questions and populations) and had a clear presentation of recommendations (i.e., specific, unambiguous, and easy-to-find key recommendations, with options for managing the different conditions or health issues). In terms of interest-holder involvement, the authors of the guideline clearly defined target users and the development groups, and reported that the views and preferences of patients were sought. The methodology for the development of the guideline was robust. The authors of the guideline clearly reported methods for evidence collection, criteria for selection, and methods for evidence synthesis. There were explicit links between recommendations and the supporting evidence and methods of formulating the recommendations. The authors of the guideline considered the health benefits and risks of side effects in formulating the recommendations. The guideline was explicit in terms of implementation and applicability, despite unclear resource implications. The authors reported that the guideline will be updated in the next 3 to 4 years. The guideline was reviewed independently by relevant professional experts and through public consultation. For editorial independence, the authors of the guideline declared the competing interests of all members in the guideline development group and disclosed that the views of the funding bodies (i.e., the Public Health Agency of Canada) had no influence on the content of the guidelines.

Overall, the included guideline^36,37 was robust in terms of scope and purpose, involvement from interested parties, rigour of development, clarity of presentation, and editorial independence.

Summary of Findings

Appendix 5 presents the main study findings.

Clinical Efficacy and Safety of Nabilone Compared With Placebo for Patients With BPSD

Key results of the clinical efficacy outcomes are outlined in Table 8, and safety outcomes are included in Table 9.

Multiple outcome measures used to assess the efficacy of nabilone included CMAI, SMMSE, SIB, NPI-NH, CMAI-IPA, and CGI. In the included RCT,¹⁸ differences in outcome measures between treatment phases were analyzed using a statistical approach that estimates how outcomes changed over time while patients were receiving treatment (a linear mixed model). Results were reported as a value (b value or beta coefficient) representing the average change in outcome scores associated with each treatment phase. The mean differences in the b values between treatment phases were then compared with corresponding MIDs to assess whether the observed effects were clinically relevant.²⁵

Agitation

The change in CMAI scores from the start of the study to week 6 was better with nabilone than with placebo, and this difference was unlikely to be due to chance. On average, scores were reduced by about 4 points more with nabilone than with placebo. This represents a moderate effect.

It is unclear whether this improvement is meaningful for patients. A 4-point change may be clinically meaningful over a short period (1 month), but a larger change (about 11 points) may be needed over longer periods (1 to 3 months). However, the change of nabilone in CMAI scores was greater than that of atypical antipsychotics, such as risperidone (1 mg/day),³⁹ or antidepressants, such as citalopram (30 mg/day),⁴⁰ which have reported improvements in CMAI scores of −1.17 points and −2.38 points compared to placebo, respectively.

Cognition

• SMMSE: The difference in SMMSE scores was statistically significant; on average, scores were about 1 point higher with nabilone compared with placebo. This improvement may be clinically meaningful, given that the range of possible effects (from 0.1 to 2.0) includes 1.4, which is considered clinically important.

• SIB: The difference in SIB scores was statistically significant; on average, scores were about 4.6 points lower with nabilone compared with placebo. However, the clinical meaningfulness of the difference was unclear due to the lack of a specific numerical MID.

• ADAS-Cog: This outcome measure was not analyzed, given that only 3 patients completed this scale, and only 1 patient had scores for both treatment phases.

Neuropsychiatric Symptoms

The difference in NPI-NH scores was statistically significant; on average, scores were about 4.6 points lower with nabilone compared with placebo. This improvement may be clinically meaningful as the MID for NPI-NH severity ranges from −3.2 to −2.8.

Caregiver Burden

The difference in NPI-NH caregiver distress scores was statistically significant; on average, scores were about 1.7 lower with nabilone compared with placebo. However, the improvement may not be clinically meaningful, given that the MID for NPI-NH caregiver distress ranges from −3.95 to −3.10.

Behaviour

The difference in behaviour assessed by CMAI-IPA subdomain scores was statistically significant; on average, scores were about 3.8 points lower with nabilone compared with placebo. A 2-point change may be clinically meaningful over a short period (at 1 month), but a larger change (about 5 points) may be needed over longer periods (at 3 months).

Global Status

On the CGIC scale, 47% of patients in the nabilone phase experienced improvement compared to 23% of patients in the placebo phase (P = 0.09).

Nutritional Status

The difference in MNA-SF scores was statistically significant; on average, scores were about 0.2 higher with nabilone compared with placebo. However, the clinical meaningfulness of the difference was unclear due to the lack of a specific numerical MID.

There were no differences between treatment phases in weight or BMI.

Pain

There were no differences between treatment phases on the PAINAD scale.

Safety

• More patients in the nabilone phase experienced TEAEs compared to the placebo phase (81.6% versus 36.8%; P = 0.05).

• More patients in the nabilone phase experienced sedation compared to the placebo phase (44.7% versus 15.8%; P = 0.02).

• There were no differences between treatment phases in other TEAEs or in SAEs.

Guidelines Regarding the Use of Nabilone for the Treatment of Patients With BPSD

Table 10 presents the recommendations of the included guideline.^36,37

Due to limited and low-quality evidence, the CCSMH guideline^36,37 conditionally recommends synthetic cannabinoids, including nabilone, for the treatment of severe agitation in patients with Alzheimer disease and related dementias if the symptoms do not respond to other pharmacological treatments.

Limitations

Evidence Gaps

No conclusions can be formed on the following research questions, given that no evidence was found:

• the clinical efficacy and safety of nabilone compared with other pharmacological treatments or nonpharmacological treatments for patients with BPSD

• the cost-effectiveness of nabilone compared with pharmacological treatments, nonpharmacological treatments, or no treatment for patients with BPSD

• the impact of nabilone on health care-related costs due to antipsychotic drug utilization in the long-term care setting.

Generalizability

The findings of the RCT¹⁸ and the recommendations of the CCSMH guideline^36,37 may be applicable to patients with dementia living in Canada, given that they were both conducted by authors in Canada.

Certainty of Evidence

Major limitations of the RCT¹⁸ included the crossover design and relatively small sample size. The results of the included RCT should be carefully interpreted, given the study limitations. Given the limited and low-quality evidence on the use of synthetic cannabinoids (including nabilone) for treatment of agitation in people with Alzheimer disease, the CCSMH guideline^36,37 recommends that synthetic cannabinoids should be reserved for severe agitation in cases in which other medications have been trialled and found to be ineffective.

Conclusions and Implications for Decision- or Policy-Making

This review included 1 RCT¹⁸ and 1 evidence-based guideline.^36,37

Clinical Efficacy and Safety of Nabilone for Treatment of BPSD

The crossover RCT by Herrmann et al. (2019)¹⁸ showed that nabilone resulted in a moderate reduction in agitation and a greater frequency of sedation compared to placebo. The trial also showed that nabilone resulted in an improvement in neuropsychiatric symptoms and overall behaviour, and had small benefits in caregiver burden, cognition, and nutrition, with no differences in weight and pain. However, the clinical meaningfulness of these observations remains to be determined.

Recommendations From the Included Evidence-Based Guideline

The 2025 CCSMH Canadian guideline^36,37 conditionally recommends synthetic cannabinoids, including nabilone, for the treatment of severe agitation in people with Alzheimer disease and related dementias if other pharmacological treatments have been trialled and found to be ineffective.

Considerations for Future Research

Clinical evidence from well-controlled studies is needed to inform decision-making with respect to the use of nabilone for the treatment of BPSD. A large, parallel, placebo-controlled trial of nabilone with longer follow-up is ongoing (NCT04516057).

Implications for Decision-Making

The evidence presented in this review is insufficient to form a strong conclusion on the use of nabilone for the treatment of BPSD. Given the limited evidence base, nabilone or other synthetic cannabinoids are currently recommended for the treatment of severe agitation in people with Alzheimer disease if symptoms remain resistant to other pharmacological treatments.

Acknowledgement

Clinical Experts

The following individuals have kindly provided comments on the report:

Shanna C. Trenaman, BScPharm, ACPR, PhD

Assistant Professor, College of Pharmacy, Faculty of Health, Dalhousie University

Affiliated Scientist, Geriatric Medicine Research, Nova Scotia Health

Dallas Seitz, MD, PhD

Chief, Division of Geriatric Psychiatry, Centre for Addiction and Mental Health

Professor, Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto

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Appendix 1: Selection of Included Studies

Note that this appendix has not been copy-edited.

Figure 1: PRISMA Flow Chart of Study Selection

PRISMA = Preferred Reporting Items for Systematic reviews and Meta-Analyses.¹⁷

Appendix 2: Lists of Included and Excluded Studies

Note that this appendix has not been copy-edited.

Table 2: Included Studies

RCT = randomized controlled trial.

Table 3: Excluded Studies

Appendix 3: Characteristics of Included Publications

Note that this appendix has not been copy-edited.

Table 4: Characteristics of Included Primary Clinical Study

ADAS-Cog = Alzheimer Disease Assessment Scale–Cognitive Subscale; ADDF = Alzheimer Drug discovery foundation; BMI = body mass index; CGIC = Clinical Global Impression–clinician-rated; CMAI = Cohen-Mansfield Agitation Inventory; IPA = International Psychogeriatric Association; MNA-SF = Mini Nutritional Assessment Short-Form; NPI-NH = Neuropsychiatric Inventory–Nursing Home version; PAINAD = Pain Assessment in Advanced Dementia; SAE = serious adverse event; SD = standard deviation; SIB = Severe Impairment Battery; SMMSE = Standardized Mini-Mental State Examination, TEAE = treatment-emergent adverse event.

^aCMAI: a 29-item scale that measures 4 domains of agitation: physical/aggressive (Questions 1 − 11), physical/nonaggressive (Questions 12 − 21), verbal/aggressive (Questions 22 − 24), and verbal nonaggressive (Questions 25 − 29). Each item is rated on a scale from 1 (never) to 7 (several times an hour). The overall CMAI total score (29 items) ranges from 29 to 203, with higher scores indicate greater agitation severity.

^bSMMSE: an 11-question measure that tests 5 areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.

^cSIB: cognition is also assessed using SIB in patients with SMMSE less than or equal to 15. It contains 6 major subscales to assess mild-to-moderate dementia; attention, orientation, language, memory, visuospatial ability, and construction. All but 2 of the SIB items are scored on a 3-point scale: 2 = correct; 1 = partially correct, and appropriate or closely related answer; and 0 = incorrect. The other 2 questions only have a 0 or a 1 point answer. Lower scores indicate greater impairment.

^dADAS-Cog: an 11-task neuropsychological assessment (0 to 70 scale) measuring dementia severity, memory, language, and praxis (motor tasks). Higher scores indicate greater impairment.

^eNPI-NH: a carer-based tool that assesses the possible presence of 12 symptoms in dementia cases, including delusions, hallucinations, apathy, depression, agitation, euphoria, aberrant motor behaviour, irritability, disinhibition, anxiety, sleeping, and eating. The greater the score, the more severe and frequent the behavioural disturbances.

^fNPI-NH caregiver distress score: a tool that measures the emotional burden and work disruption of caregiver caused by dementia-related behaviours by using a 6-point scale (0 to 5) per symptom listed in NPI-NH (e.g., agitation, delusions, or apathy) with 0 being “not at all” and 5 being “extremely” distressing. Higher scores indicate higher levels of stress and burden on caregiver.

^gCMAI IPA: derived from the 29-item questionnaire of CMAI by selecting items that align with the 3 main IPA Provisional Research Criteria for Agitation (i.e., physical aggression, verbal aggression, and physical nonaggression/restlessness). Higher scores indicate more severe, frequent agitation.

^hCGIC: a 7-point scale used in clinical trials and practice to measure a patient’s improvement or decline after treatment. It assesses overall effectiveness of the treatment, typically ranging from "very much improved" to "very much worse." Usually, the scale is 1-7: 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change, 5) Minimally worse, 6) Much worse, 7) Very much worse.

^IMNA-SF: a screening tool used to categorize patients as malnourished or at risk of malnutrition. It contains 6 questions accessing recent changes in appetite, weight loss, mobility, psychological stress/ acute disease, current neuropsychological problems, and BMI.

^jPAINAD: a tool used to evaluate pain in individuals with dementia or cognitive impairment who cannot verbally communicate their pain. It assesses 5 behaviours: breathing, negative vocalization, facial expression, body language, and consolability, with total scores ranging from 0 (no pain) to 10 (severe pain).

Table 5: Characteristics of the Included Guideline

BPSD = behavioural and psychological symptoms of dementia; CCSMH = Canadian Coalition for Seniors’ Mental Health; GRADE = Grading of Recommendations Assessment, Development and Evaluation.

Appendix 4: Critical Appraisal of Included Publications

Note that this appendix has not been copy-edited.

Table 6: Risk of Bias Assessment of the Included Study Using the Revised Cochrane Risk of Bias Tool for Randomized Trials (RoB 2)

AE = adverse event; N = no; NA = not applicable; PLB = placebo; PN = probably no; PY = probably yes; SAE = serious adverse event; Y = yes.

Source: The Revised Cochrane Risk of Bias Tool for Randomized Trials (RoB 2)¹⁵

Table 7: Strengths and Limitations of Guideline Using AGREE II

AGREE II = Appraisal of Guidelines for Research and Evaluation II.¹⁶

^aWherever possible, Canada’s Drug Agency no longer uses the term stakeholder because of its harmful association with colonialism; in this case, the word appears in the original phrasing of AGREE II.

Appendix 5: Main Study Findings

Note that this appendix has not been copy-edited.

Table 8: Summary of Comparative Clinical Efficacy Findings

ADAS-Cog = Alzheimer Disease Assessment Scale–Cognitive Subscale; BMI = body mass index; CGI-I = Clinical Global Impression–Improvement; CI = confidence interval; CMAI = Cohen-Mansfield Agitation Inventory; IPA = International Psychogeriatric Association; MNA-SF = Mini Nutritional Assessment Short-Form; NPI-NH = Neuropsychiatric Inventory–Nursing Home version; PAINAD = Pain Assessment in Advanced Dementia; SIB = Severe Impairment Battery; SMMSE = Standardized Mini-Mental State Examination; vs. = versus.

Table 9: Summary of Comparative Safety Findings

NPS = neuropsychiatric symptoms; SAE = serious adverse event; TEAE = treatment-emergent adverse event; UTI = urinary tract infection; vs. = versus.

Table 10: Summary of Recommendations in the Included Guideline

CCSMH = Canadian Coalition for Seniors’ Mental Health; RCT = randomized controlled trial; vs. = versus.