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To Evaluate the Efficacy, Safety, and Tolerability of Dronabinol Oral Solution for Agitation in Patients With Alzheimer's Disease

NCT07422311 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-02-25

No results posted yet for this study

Summary

This study tests a medication called dronabinol in people with Alzheimer's disease. First, participants go through up to 4 weeks of screening. Then, over 2 weeks, the dose of the study drug is slowly increased. For the next 10 weeks, participants stay on either dronabinol or a placebo.

After finishing this part of the study, participants can join a 6-month extension where everyone receives dronabinol. Those already on the drug stay on their same dose, while those who were on placebo gradually increase their dose over 2 weeks.

All participants take dronabinol for the rest of the extension, then complete a final safety check 4 weeks after stopping the medication. Usual medical treatments are continued throughout the study.

Conditions

  • Agitation in Dementia

Interventions

DRUG

Dronabinol Oral Solution

Dronabinol Oral Solution for Agitation in Patients with Alzheimer's Disease

OTHER

Placebo Control

Placebo (no THC)

Sponsors & Collaborators

  • Mandara

    collaborator UNKNOWN

  • Benuvia Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Lauren Priest, MD · Division of Rehabilitation, Aged Care and Palliative Care Flinders Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-05-30
Completion
2028-08-01
FDA Drug
Yes

Countries

  • Australia

Study Locations

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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 NCT07422311 on ClinicalTrials.gov