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Synthetic Cannabinoid

Nabilone for Agitation in Alzheimer's Disease (NAB-IT Trial)

Phase 3
Recruiting
Led By Giovanni Marotta, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks) to 8 weeks
Awards & highlights

NAB-IT Trial Summary

This trial will help to determine whether nabilone is an effective treatment for agitation in Alzheimer's disease patients.

Who is the study for?
This trial is for men and women over 55 with Alzheimer's who experience significant agitation. Women must be post-menopausal, and participants should have a stable dose of cognitive-enhancing meds for at least 3 months. They need a caregiver who speaks English well. People using cannabis recently, on certain drugs, or with uncontrolled heart disease or liver issues can't join.Check my eligibility
What is being tested?
The study tests if nabilone helps reduce agitation in Alzheimer's patients compared to a placebo over an 8-week period. It also examines its effects on neuropsychiatric symptoms, caregiver stress, cognition, nutrition, and pain. Participants are randomly assigned to either the drug or placebo group.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of cannabinoids like nabilone may include dizziness, dry mouth, sleepiness or feeling high. Since it's being tested in elderly patients with AD who might be sensitive to medications' effects; monitoring will be crucial.

NAB-IT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience severe restlessness as defined by health professionals.
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My medication for memory or thinking problems has been the same for the last 3 months.
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I am a man or a post-menopausal woman aged 55 or older.
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I have been diagnosed with major memory or thinking problems due to Alzheimer's disease.
Select...
I have a caregiver who can join me for study visits and is fluent in English.

NAB-IT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0 weeks) to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 weeks) to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Agitation - Cohen-Mansfield Agitation Inventory (CMAI)
Secondary outcome measures
Behaviour - Neuropsychiatric Inventory - Nursing Home (NPI-NH)
Cognition - Standardized Mini-Mental State Examination (sMMSE)
Global Change - Alzheimer's Disease Cooperative Study - Clinical Global Impression of Severity/Change (ADCS-CGIS/C)
+3 more
Other outcome measures
Sedation - Udvalg for Kliniske Undersøgelser (UKU) Side-Effect Rating Scale

NAB-IT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nabilone ArmExperimental Treatment1 Intervention
Participants randomized to the nabilone arm will be titrated up to a maximum dose of 2 mg/day.
Group II: Placebo ArmPlacebo Group1 Intervention
Participants randomized to the placebo arm will receive placebo capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nabilone
2014
Completed Phase 3
~730

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
654 Previous Clinical Trials
1,543,185 Total Patients Enrolled
1 Trials studying Agitation
38 Patients Enrolled for Agitation
Alzheimer's Drug Discovery FoundationOTHER
21 Previous Clinical Trials
3,029 Total Patients Enrolled
Weston Brain InstituteOTHER
11 Previous Clinical Trials
861 Total Patients Enrolled

Media Library

Nabilone (Synthetic Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04516057 — Phase 3
Agitation Research Study Groups: Nabilone Arm, Placebo Arm
Agitation Clinical Trial 2023: Nabilone Highlights & Side Effects. Trial Name: NCT04516057 — Phase 3
Nabilone (Synthetic Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04516057 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other similar studies to the one using Nabilone?

"At the moment, there are six ongoing clinical trials evaluating nabilone. Three of those studies have reached Phase 3. Most research on nabilone is conducted in Toronto, Ontario; however, there are nine total locations running these investigations."

Answered by AI

What have been patients' reactions to Nabilone?

"Given that this is a Phase 3 trial with data supporting efficacy and safety, our team has rated the safety of Nabilone as a 3."

Answered by AI

Are we looking for more participants in this clinical trial at the moment?

"Yes, this trial is still looking for patients and the most recent information available was published on August 5th, 2022. The study was originally posted on February 1st, 2021."

Answered by AI

How many people are eligible to participate in this clinical trial?

"Yes, the information on clinicaltrials.gov suggests that this trial is actively recruiting participants. The clinical trial was initially posted on 2/1/2021 and was most recently updated on 8/5/2022. The trial is recruiting for 112 participants across 5 sites."

Answered by AI
~36 spots leftby Oct 2025