NCT05612711

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ralph H. Johnson VA Medical Center · Federal
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to study the effects of dronabinol in US Veterans with agitation related to moderate to severe dementia. The main goals of the study are: * To evaluate the efficacy of dronabinol for the treatment of agitation in moderate to severe dementia compared to placebo * To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia compared to placebo Fifty (50) subjects will be given either dronabinol or placebo for 8 weeks. All subjects will then undergo a "washout" phase for 3 weeks, followed by the crossover intervention (i.e. subjects who received placebo during the first phase will receive dronabinol during the second phase, and vice versa). Thus, all participants will be taking dronabinol at some point during the study. During the study, subjects will undergo evaluations for: * Agitation * Cognitive changes * Physical changes (i.e. labs, ekg, physical exam)

Detailed description

The investigators will conduct a phase IIa study to evaluate the efficacy and safety of dronabinol in the treatment of agitation related to dementia in the US Veteran population. Specific Aim 1 - To evaluate the efficacy of dronabinol (target dose 5 mg bid) for the treatment of agitation in dementia. Hypothesis: Dronabinol improves clinically significant agitation in moderate to severe dementia. Approach: The investigators will conduct a 6-week, double-blind, placebo-controlled, crossover, exploratory study of 50 Veterans suffering from moderate to severe dementia and clinically significant agitation with the Cohen Mansfield Agitation Inventory (CMAI) total score as the main outcome measure. Impact: The potential benefit of dronabinol in agitation will be evaluated. Specific Aim 2 - To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia. Hypothesis: Dronabinol is safe for the treatment of agitation in moderate to severe dementia. Approach: Outcomes of safety monitoring are to be measured by physical examination, vital signs with weight, adverse event reports, electrocardiogram, safety labs including complete metabolic panel (CMP), complete blood count (CBC), urinalysis (UA), and treatment compliance. Impact: The potential adverse effects of the 5 mg dose of dronabinol will be evaluated. Exploratory Aims - The investigators will also evaluate the effect of dronabinol on neuropsychiatric symptoms, caregiver distress, cognition, weight, nutritional status, pain, and inflammation.

Conditions

• Dementia Moderate
• Dementia Severe
• Agitation,Psychomotor
• Behavioral Symptoms

Interventions

Type	Name	Description
DRUG	Dronabinol	All participants will take both dronabinol and placebo at different points in the study in this crossover design trial.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2022-11-10
• Last updated: 2024-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study