MedTrace Logo

Dronabinol for Agitation in Dementia Crossover Trial

NCT05612711 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-07-05

No results posted yet for this study

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)

Conditions

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

Interventions

DRUG

Dronabinol

All participants will take both dronabinol and placebo at different points in the study in this crossover design trial.

Sponsors & Collaborators

  • JHSPH Center for Clinical Trials

    collaborator OTHER

  • Ralph H. Johnson VA Medical Center

    lead FED

Principal Investigators

  • Jacobo E Mintzer, MD · Ralph H. Johnson VA Healthcare System

  • Jessica E Broadway, MD · Ralph H. Johnson VA Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2025-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05612711 on ClinicalTrials.gov