WithdrawnPhase 2

Dronabinol for Agitation in Dementia Crossover Trial

Single-site, Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Dronabinol for the Treatment of Agitation in Outpatient With Dementia

Lead sponsor

Ralph H. Johnson VA Medical Center

Asset

Dronabinol

Listed sites

Recruiting sites

Enrollment

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Study partner/caregiver required

Primary endpoints

•Agitation, Cohen Mansfield Agitation Inventory (CMAI)•Safety and tolerability, Treatment Emergent Adverse Events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID1I01CX002671

NCT IDNCT05612711

Timeline

Milestones

Study first posted2022-11-10actual

Study start2023-11estimated (month precision)

Last update posted2024-07-05actual

Primary completion2025-11estimated (month precision)

Study completion2026-11estimated (month precision)

Assets

Drug assets

Dronabinol

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•US Veteran who is not pregnant or unable to become pregnant

•Diagnosis of Major Neurocognitive Disorder (aka dementia) of any type

•Functional Assessment Staging Test (FAST) score of 5 or higher

•Presence of clinically significant agitation and/or irritability with an NPI subscale score greater than or equal to 4

•If treated with cholinesterase inhibitors or memantine, dosage must be stable for 3 months, or if discontinued they may enroll after 1 month

•Must be able to swallow capsules

•Must meet International Psychogeriatric Association's provisional definition of agitation in dementia.

•Must have decisional capacity to sign informed consent or have a legally authorized representative available to provide consent

•Must have an available study partner who spends at least 10 hours per week with the subject

Exclusion criteria

•Psychotropic medication changes (i.e. concomitant antidepressants, antipsychotics) less than 1 month prior to study randomization

•Contraindications to dronabinol (hypersensitivity or allergy to any cannabinoid or sesame oil)

•Use of cannabinoids (including over the counter products such as "CBD" or medical cannabis) or other illicit drugs in the past 3 months

•History of psychotic symptoms due to another psychiatric illness other than dementia int he past 2 years.

•Unstable current psychiatric disorder or neurologic condition (i.e. unstable depression, bipolar disorder, epilepsy, etc.) other than agitation or psychosis due to dementia.

•Suicidal ideations in the past 3 months or attempts in the past year

•Clinically significant delusions and/or hallucinations which are considered by the PI's to be a contraindication for dronabinol use

•Taking 1 or more medications which in the judgement of the PI's can be contraindicated with the use of dronabinol

•Unstable or uncontrolled medical conditions including cardiovascular system issues (i.e. angina, cardiac arrhythmias, recurrent syncope, hypertension, etc) as judged by the PI's.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Global cognition

Safety / tolerability / PK

Other (unclassified)

Other clinical outcomes