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Cannabinoid

Nabilone for Frontotemporal Dementia (Nabilone-FTD Trial)

Phase 2

Waitlist Available

Research Sponsored by Simon Ducharme, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Major neurocognitive disorder due to probable behavioural variant FTD (Rascovsky criteria) or primary progressive aphasia (Gorno-Tempini criteria)

Available study partner with ≥10 hours per week in-person contact with the patient

Must not have

Major depressive episode within 6 months of screening

Ongoing use of any cannabinoid-related products

Timeline

Screening 3 weeks

Treatment Varies

Follow Up is 4-hne associated with cmai scores at baseline or with change in cmai scores after 6-weeks of nabilone treatment (i.e. between baseline and outcome assessments)?

Summary

This trial will test if oral nabilone reduces agitation in those with Frontotemporal Dementia, a form of dementia that affects behavior and language.

Who is the study for?

This trial is for adults over 18 with Frontotemporal Dementia who experience significant agitation. Participants must be able to consent or have a surrogate decision-maker, not plan to change their psychoactive meds during the trial, and have a study partner available weekly. Excluded are those with allergies to cannabinoids, recent major depression, drug/alcohol abuse history, certain cardiovascular issues, severe liver dysfunction, or other conditions causing agitation.

What is being tested?

The trial is testing if nabilone can reduce agitation in patients with Frontotemporal Dementia compared to a placebo. It's designed for those meeting specific criteria for behavioral variant FTD or primary progressive aphasia and experiencing notable agitation as per International Psychogeriatric Association standards.

What are the potential side effects?

Potential side effects of nabilone may include dizziness due to low blood pressure when standing up (orthostatic hypotension), mood changes like feeling depressed or anxious, hallucinations or delusions (psychotic symptoms), and possibly worsening of pre-existing heart conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of cognitive disorder.

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I have someone who can be with me for at least 10 hours a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a major depressive episode in the last 6 months.

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I am currently using products that contain cannabinoids.

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I experience significant dizziness when standing up.

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I experience a fast heartbeat when standing up.

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I experience strong delusions or hallucinations.

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I am currently pregnant or breastfeeding.

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I have severe liver problems.

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I have a mental or brain condition that makes me very restless.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ is 4-hne associated with cmai scores at baseline or with change in cmai scores after 6-weeks of nabilone treatment (i.e. between baseline and outcome assessments)?

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~is 4-hne associated with cmai scores at baseline or with change in cmai scores after 6-weeks of nabilone treatment (i.e. between baseline and outcome assessments)?

This trial's timeline: 3 weeks for screening, Varies for treatment, and is 4-hne associated with cmai scores at baseline or with change in cmai scores after 6-weeks of nabilone treatment (i.e. between baseline and outcome assessments)? for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohen Mansfield Agitation Inventory (CMAI)

Secondary study objectives

4-hydroxynonenal (4-HNE)

Tumor necrosis factor alpha (TNFα)

Other study objectives

Adverse drug reaction (ADR) to varying doses of nabilone

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: NabiloneActive Control1 Intervention

Weeks 1-2 Nabilone and placebo will be taken orally by the patient as per the schedule provided by the research team. All patients will start with one 0.5mg capsule per day, taken before bed for the first week and then increase administration to the 1mg capsule taken before bed for the second week. Weeks 3-4 Two weeks after the start of the trial patients and study partners will attend an in person or remote Interim Assessment. If remission is not achieved and no clinically significant adverse drug reactions are reported then the dose schedule will increase to 2 capsules per day (2mg/day), 1 capsule in the morning and 1 before bed. Weeks 5-6 Four weeks after the start of the trial there will be a second in person or remote Interim Assessment identical to the first. If remission of agitation has not been achieved and no adverse drug reactions are reported the dose schedule will increase to 4 tablets per day (4mg/day), with 2 tablets in the morning and 2 before bed.

Group II: PlaceboPlacebo Group1 Intervention

Weeks 1 and 2 Participants will receive one capsule per day to be taken orally before bedtime. Weeks 3-4 Participants will receive 2 capsules per day, one in the morning and one before bedtime. Weeks 5-6 Participants will receive 2 capsules per day, one in the morning and one before bedtime. The placebo dosing regimen is designed to be as similar as possible to the nabilone dosing regime, including using identical capsules.

0 / 10Eligibility criteria met