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Alzheimer DiseasePhase 3NAB-ITNCT04516057

Nabilone for Agitation Blinded Intervention Trial

A Phase 3 study testing Nabilone in people with Alzheimer Disease and Agitation, run by Sunnybrook Health Sciences Centre at 6 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Alzheimer Disease, Agitation
What is being tested?
Nabilone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
6 sitesCanada
Study dates
1 Feb 2021to Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females ≥55 years of age; females must be post-menopausal
  • Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria for Major Neurocognitive Disorder due to AD. Patients with Major Neurocognitive Disorder due to multiple etiologies (AD and vascular) will be included
  • sMMSE ≤24
  • Presence of clinically significant agitation based on the IPA definition
  • If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months prior to study randomization
  • Availability of a primary caregiver to accompany the participant to study visits and to participate in the study. The primary caregiver must be sufficiently proficient in English to complete the required study assessments, as per investigator judgement.

Who cannot join

  • Change in psychotropic medications less than 1 week prior to study randomization (e.g., concomitant antidepressants)
  • Contraindications to cannabinoids, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions
  • Current uncontrolled cardiovascular disease (e.g. uncontrolled hypertension, ischemic heart disease, arrhythmia and severe heart failure), as per investigator assessment
  • Current significant liver disease, as per investigator assessment
  • Presence or history of other psychiatric disorders or neurological conditions (e.g. psychotic disorders, schizophrenia, stroke, epilepsy)
  • Participants currently meeting DSM 5 criteria for Major Depressive Episode (MDE)
Show all 9Show fewer
  • Previous or current abuse of/dependence on marijuana
  • Clinically significant delusions and/or hallucinations (NPI-NH delusion/hallucinations subscore ≥4)
  • Reported recreational use of marijuana or other cannabis products within 3 months prior to study randomization

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

NAB-IT Coordinating Centre contact

416-480-6100 ext. 5630

NAB-IT@sunnybrook.ca

6 sites in 1 country

Canada6 sites, 6 recruiting

  • University of Calgary

    Calgary, Alberta, T2N 4N1

    Ramnik Sekhon, ramnik.sekhon@ucalgary.ca

    Recruiting

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

    Adriana Diez, 519-685-8500 ext. 77024, Adriana.Diez@lhsc.on.ca

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Kate Survilla, 416-480-6100 ext. 63185, kate.survilla@sri.utoronto.ca

    Recruiting

  • Centre for Addiction and Mental Health

    Toronto, Ontario

    Loreque Fearon, NAB-IT@camh.ca

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario

    Adrienne Atayde, Adrienne.Atayde@unityhealth.to

    Recruiting

  • Ontario Shores Centre for Mental Health Sciences

    Whitby, Ontario, L1N 5S9

    Heather Daly, dalyh@ontarioshores.ca

    Recruiting

Other trials in Canada

About this study

This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms. Agitation is associated with faster progression to institutionalization, increased caregiver burden, poorer quality of life, and increased risk of death. In addition, current pharmacological options show only modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more effective treatments for agitation in AD is a clinical and research priority.

Nabilone is a synthetic cannabinoid that is Health Canada-approved to treat chemotherapy-induced nausea and vomiting.

Read more

The PI's research group completed a 6-week double-blind placebo-controlled randomized cross-over pilot trial in 38 patients with moderate-to-severe AD, providing the first preliminary evidence regarding the safety and efficacy of nabilone in this population. They found that nabilone significantly improved agitation, overall neuropsychiatric symptoms, and caregiver distress. That study was limited by its sample size and questions remain regarding the efficacy of nabilone for nutrition and pain and predictors of response. However, the promising preliminary findings encourage a pivotal, practice-changing phase III trial to inform clinical practice.

Participants in this study will be randomized to receive either nabilone or a placebo for 8 weeks. In addition to looking at the effectiveness of nabilone in treating agitation, the researchers will also look at whether it is beneficial for other relevant outcomes for patients with AD including overall neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, and pain. Participants will also be followed for 8 weeks following completion of the study treatment.

Being tested
Nabilone, Placebo
Keywords
Cannabis, Cannabinoid, THC
Medical subject headings
Alzheimer Disease, Psychomotor Agitation, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NabiloneDrug

    Also called Cesamet

    After the screening period, participants randomized to the nabilone arm will receive nabilone for 8 weeks. Participants will then be followed for 8 weeks following completion of the study treatment.

  • PlaceboOther

    After the screening period, participants randomized to the placebo arm will receive placebo capsules for 8 weeks. Participants will then be followed for 8 weeks following completion of the study treatment.

Study groups in NCT04516057
Study groupRoleWhat they receive
Nabilone ArmExperimentalParticipants randomized to the nabilone arm will be titrated up to a maximum dose of 2 mg/day.
Receives: Drug: Nabilone
Placebo ArmPlacebo comparatorParticipants randomized to the placebo arm will receive placebo capsules.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agitation - Cohen-Mansfield Agitation Inventory (CMAI)

    A 29-point scale that measures agitation in two dimensions, verbal and physical, each of which having two poles, aggressive and non-aggressive. Scores range from 29-203 points, with a higher score indicating a worse outcome. This includes the CMAI IPA Agitation Score \& CMAI IPA Delphi Modification, which are derived from the CMAI.

    Measured: Baseline (0 Weeks) to 8 Weeks

Secondary outcomes (6)

  1. Behaviour - Neuropsychiatric Inventory - Nursing Home (NPI-NH)

    A widely used assessment of behaviour disturbances in dementia, including: apathy, agitation, delusions, hallucinations, depression, euphoria, aberrant motor behaviour, irritability, disinhibition, anxiety, sleeping, and eating. The frequency and severity of these symptoms are judged on a 4-point and 3-point scale, respectively. Scores range from 0-144 points, with a higher score indicating a worse outcome.

    Measured: Baseline (0 Weeks) to 8 Weeks

  2. Cognition - Standardized Mini-Mental State Examination (sMMSE)

    Measures global cognition, and assesses orientation to time and place, immediate recall, short-term verbal memory, calculation, language, and construct ability. Scores range from 0-30 points, with a lower score indicating a worse outcome.

    Measured: Baseline (0 Weeks) to 8 Weeks

  3. Weight

    Measured: Baseline (0 Weeks) to 8 Weeks

  4. Nutritional Status - Mini Nutritional Assessment - Short Form (MNA-SF)

    A structured interview consisting of 6 items that categorizes patients as malnourished, at risk of malnutrition, or of normal nutritional status. Scores range from 0-14 points, with a lower score indicating a worse outcome.

    Measured: Baseline (0 Weeks) to 8 Weeks

  5. Pain - Pain Assessment Checklist for Seniors with Limited Ability to Communicate-II (PACSLAC-II)

    A 31-item observer-rated scale assessing facial expressions, activity/body movements, social/personality/mood indicators and mental status changes. Scores range from 0-31 points, with a higher score indicating a worse outcome.

    Measured: Baseline (0 Weeks) to 8 Weeks

  6. Global Change - Alzheimer's Disease Cooperative Study - Clinical Global Impression of Severity/Change (ADCS-CGIS/C)

    A commonly-used clinician-rated scale that quantifies disease severity and clinical change (worsening, no change, or improvement), based on information regarding the patient's medical history, cognition, behaviour, and function. Numerical scores are not assigned.

    Measured: Baseline (0 Weeks) to 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2020
  2. Study start1 Feb 2021
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04516057
Sponsor's protocol ID
1968
Acronym
NAB-IT
Status last verified
Jan 2026
First submitted
5 Aug 2020
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Herrmann N, Ruthirakuhan M, Gallagher D, Verhoeff NPLG, Kiss A, Black SE, Lanctot KL. Randomized Placebo-Controlled Trial of Nabilone for Agitation in Alzheimer's Disease. Am J Geriatr Psychiatry. 2019 Nov;27(11):1161-1173. doi: 10.1016/j.jagp.2019.05.002. Epub 2019 May 8.

    PubMed 31182351

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nabilone in people with Alzheimer Disease and Agitation, run by Sunnybrook Health Sciences Centre at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact NAB-IT Coordinating Centre (416-480-6100 ext. 5630, NAB-IT@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agitation - Cohen-Mansfield Agitation Inventory (CMAI) (time frame: Baseline (0 Weeks) to 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04516057, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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