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Cannabinoid
Dronabinol for Agitation in Dementia
Phase 2
Waitlist Available
Led By Jacobo E Mintzer, MD
Research Sponsored by Ralph H. Johnson VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of clinically significant agitation and/or irritability with an NPI subscale score greater than or equal to 4
Must meet International Psychogeriatric Association's provisional definition of agitation in dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks) to 18 weeks
Awards & highlights
Study Summary
This trial investigates the effects of dronabinol on agitation in Veterans with moderate to severe dementia. Subjects will receive dronabinol or placebo & be evaluated for changes in agitation, cognition & physical health.
Who is the study for?
This trial is for US Veterans with moderate to severe dementia experiencing significant agitation. Participants must have a stable medication regimen, be able to swallow capsules, and not use cannabinoids or illicit drugs recently. They need a study partner who spends at least 10 hours per week with them and cannot have unstable psychiatric disorders or medical conditions.Check my eligibility
What is being tested?
The trial tests the effectiveness of dronabinol in treating agitation in dementia patients compared to a placebo. Each participant will receive both treatments over two phases (8 weeks each) separated by a washout period, ensuring everyone gets dronabinol at some point.See study design
What are the potential side effects?
Potential side effects of dronabinol may include mood changes, dizziness, sleepiness, confusion, hallucinations or worsening of pre-existing heart conditions due to its psychoactive properties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I often feel very agitated or irritable.
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I have been diagnosed with agitation related to dementia.
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I can make my own medical decisions or have someone legally able to do so for me.
Select...
I have someone who can be with me for at least 10 hours a week.
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I have been diagnosed with a type of dementia.
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I can swallow pills without difficulty.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (0 weeks) to 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0 weeks) to 18 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in agitation, Cohen Mansfield Agitation Inventory (CMAI)
Safety and tolerability, Treatment Emergent Adverse Events
Secondary outcome measures
Change in QTc interval on Electrocardiogram (EKG)
Change in agitation, Neuropsychiatric Inventory (NPI)
Change in blood pressure
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Placebo FirstExperimental Treatment1 Intervention
Participants will take matching placebo capsules twice daily for 8 weeks, followed by a three week washout period. They will then begin taking dronabinol 2.5 mg capsules twice daily for 1 week, followed by dronabinol 5 mg twice daily for 6 weeks, followed by dronabinol 2.5 mg twice daily for 1 week.
Group II: Dronabinol FirstExperimental Treatment1 Intervention
Participants will take Dronabinol 2.5 mg capsules twice daily for 1 week, followed by dronabinol 5 mg twice daily for 6 weeks, followed by dronabinol 2.5 mg twice daily for 1 week. They will then undergo a 3-week washout period, followed by placebo capsules twice daily for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
2003
Completed Phase 4
~2080
Find a Location
Who is running the clinical trial?
Ralph H. Johnson VA Medical CenterLead Sponsor
18 Previous Clinical Trials
5,544 Total Patients Enrolled
JHSPH Center for Clinical TrialsOTHER
11 Previous Clinical Trials
9,532 Total Patients Enrolled
2 Trials studying Psychomotor Agitation
373 Patients Enrolled for Psychomotor Agitation
Jacobo E Mintzer, MDPrincipal InvestigatorRalph H. Johnson VA Healthcare System
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I often feel very agitated or irritable.I have been diagnosed with agitation related to dementia.I do not have severe delusions or hallucinations that would make dronabinol unsafe for me.I can make my own medical decisions or have someone legally able to do so for me.I have had psychotic symptoms from a mental health condition other than dementia in the last 2 years.I have someone who can be with me for at least 10 hours a week.I have not used cannabinoids or illicit drugs in the last 3 months.I do not have an unstable psychiatric or neurological condition.My heart and blood pressure conditions are stable.I am not allergic to cannabinoids or sesame oil.I am on medication that may not mix well with dronabinol.You have a FAST score of 5 or more.I have been diagnosed with a type of dementia.My medication for memory issues has been stable for 3 months or stopped for 1 month.I haven't changed my mental health medications in the last month.You have thought about hurting yourself in the last 3 months or tried to hurt yourself in the last year.I can swallow pills without difficulty.
Research Study Groups:
This trial has the following groups:- Group 1: Dronabinol First
- Group 2: Placebo First
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the objectives of this experiment?
"The primary intention of this trial, monitored for 18 weeks from the Baseline stage (0 Weeks), is to measure agitation levels using Cohen Mansfield Agitation Inventory (CMAI). Also being measured are pain with Pain Assessment in Advanced AD (PAIN-AD) scale which scores between 0 and 10; cognition via Alzheimer's disease Assessment Scale - Cognitive Section (ADAS-Cog) whose values range from 0 to 70; and nutritional status through prealbumin concentrations ranging in milligrams per decilitre."
Answered by AI
Are there currently any openings in this trial for participants?
"Confirming the information that is available on clinicaltrials.gov, this trial has ended its recruitment phase and is no longer enrolling patients. It was initially posted in November 1st 2023 and last updated on November 4th 2022; however, there are a multitude of other studies actively seeking participants which total 806 at the moment."
Answered by AI
What perils could one encounter when using Dronabinol First?
"Dronabinol First was assigned a safety score of 2 due to the existence of Phase 2 trial data demonstrating its relative security, but no evidence yet exists supporting its efficacy."
Answered by AI
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