Clinical Trials Logo

Clinical Trial 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)


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05612711
Study type Interventional
Source Ralph H. Johnson VA Medical Center
Contact Jacobo E Mintzer, MD
Phone 843-367-4260
Email jacobo.mintzer@va.gov
Status Not yet recruiting
Phase Phase 2
Start date November 2023
Completion date November 2026

See also
  Status Clinical Trial Phase
Completed NCT01217541 - Collaboration Between Department of Old Age Psychiatry and Nursing Homes N/A
Completed NCT00365859 - Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD) Phase 3
Recruiting NCT03624348 - The Impact of 8 Weeks of a Digital Meditation Application on Work Stress N/A
Recruiting NCT03670446 - Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants:A Study on Behavioral Patterns N/A
Completed NCT04091633 - School Health Implementation Network: Eastern Mediterranean N/A
Withdrawn NCT00375557 - Safety and Efficacy of Divalproex and Quetiapine in Elderly Alzheimer's Dementia Patients Phase 4
Completed NCT00479271 - Evaluating the Effectiveness of a Community Based Intervention for Persons With Dementia and Their Caregivers in a Developing Country N/A
Completed NCT04587583 - WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers Phase 1/Phase 2
Recruiting NCT05591820 - A Randomized Controlled Trial on Brief Behavioral Parent Training N/A
Completed NCT03464955 - VR Usage in Non-Invasive Surgical Sub-Specialty Procedures N/A
Recruiting NCT04066985 - Targeting Adolescent Depressive Symptoms Via Brief, Web-Based Interventions N/A
Completed NCT04096274 - Working to Implement and Sustain Digital Outcome Measures N/A
Completed NCT03376633 - The Impact of a School-Based, Trauma-Informed CBT Intervention for Young Women N/A
Recruiting NCT03506672 - Assessing the Effectiveness of an Approach for Vocal Behaviors in Older People Living in Nursing Homes N/A
Completed NCT02069912 - Multifaceted Depression and Cardiovascular Program N/A
Active, not recruiting NCT05353049 - How to Bathe a Person With Dementia? A Bathing Intervention Based on Basale Stimulation® for People With Moderate to Severe Dementia N/A
Completed NCT05599100 - Virtual Training for Latino Caregivers to Manage Symptoms of Dementia N/A
Recruiting NCT05989646 - Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children N/A
Completed NCT05384704 - A Single Group Study of Empower@Home-an Internet Cognitive Behavioral Therapy Intervention N/A
Completed NCT02794051 - Transdiagnostic Group Intervention for Children With Behavior Problems N/A