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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
Males or females ≥55 years of age; females must be post-menopausal
Must not have
Contraindications to cannabinoids, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions
Presence or history of other psychiatric disorders or neurological conditions (e.g. psychotic disorders, schizophrenia, stroke, epilepsy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks) to 8 weeks
Awards & highlights
Pivotal 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.
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.
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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to cannabis or its products and do not have drug interactions.
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I have a history of psychiatric or neurological conditions.
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I do not have any uncontrolled heart problems.
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My doctor has diagnosed me with a serious liver condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Agitation - Cohen-Mansfield Agitation Inventory (CMAI)
Secondary study objectives
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)
+2 more
Other study objectives
Sedation - Udvalg for Kliniske Undersøgelser (UKU) Side-Effect Rating Scale

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
681 Previous Clinical Trials
1,565,646 Total Patients Enrolled
1 Trials studying Agitation
38 Patients Enrolled for Agitation
Alzheimer's Drug Discovery FoundationOTHER
21 Previous Clinical Trials
3,002 Total Patients Enrolled
Weston Brain InstituteOTHER
11 Previous Clinical Trials
861 Total Patients Enrolled
Giovanni Marotta, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
Krista L. Lanctôt, PhDPrincipal InvestigatorSunnybrook Research Institute
2 Previous Clinical Trials
78 Total Patients Enrolled
1 Trials studying Agitation
38 Patients Enrolled for Agitation
Nathan Herrmann, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
7 Previous Clinical Trials
364 Total Patients Enrolled
1 Trials studying Agitation
38 Patients Enrolled for Agitation

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
~18 spots leftby Oct 2025
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