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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

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)?

Awards & highlights

Nabilone-FTD Trial 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.Check my eligibility

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.See study design

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.

Nabilone-FTD Trial 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.

Nabilone-FTD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cohen Mansfield Agitation Inventory (CMAI)

Secondary outcome measures

4-hydroxynonenal (4-HNE)

Tumor necrosis factor alpha (TNFα)

Other outcome measures

Adverse drug reaction (ADR) to varying doses of nabilone

Nabilone-FTD 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 / 2Eligibility criteria met

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Who is running the clinical trial?

Simon Ducharme, MDLead Sponsor

Alzheimer's Drug Discovery FoundationOTHER

21 Previous Clinical Trials

3,096 Total Patients Enrolled

3 Trials studying Frontotemporal Dementia

162 Patients Enrolled for Frontotemporal Dementia

Frequently Asked Questions

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

In what ways can Nabilone pose a hazard to individuals?

"The safety profile of nabilone was scored as a 2, meaning there is limited data confirming its efficacy but evidence suggests it has no major adverse effects."

Answered by AI

Is enrollment currently open for this experiment?

"According to the clinicaltrials.gov website, this particular medical trial is no longer seeking out patients for its research endeavour. Although it was initially posted on March 7th 2023 and updated October 12th of that same year, there are 882 other studies which are actively recruiting participants at present time."

Answered by AI

Are there multiple venues across the state running this research project?

"This study has 7 available sites, including the Brain and Mind Institute, University of Western Ontario in London, Sunnybrook Health Sciences Centre in Toronto, Baycrest Hospital at Laval University plus 4 other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nabilone for Agitation in Frontotemporal Dementia

Simon Ducharme, MD 2023. "Nabilone for Agitation in Frontotemporal Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05742698.

All > Aphasia > Frontotemporal Dementia