MedTrace Logo

Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease

NCT04436081 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-02-16

No results posted yet for this study

Summary

This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to 1) determine the efficacy of THC-free cannabidiol (CBD oil) in reducing the severity of agitation among participants and 2) determine whether THC-free CBD oil can reduce the burden on caregivers and increase the participants' quality of life.

Conditions

  • Alzheimer Disease
  • Dementia
  • Major Neurocognitive Disorder With Aggressive Behavior

Interventions

DRUG

THC-free CBD Oil

Hemp-based CBD oil Gelcaps

DRUG

Placebo

Placebo Gelcaps

Sponsors & Collaborators

  • Old Dominion University

    collaborator OTHER

  • Ananda Hemp, Inc.

    collaborator UNKNOWN

  • Eastern Virginia Medical School

    lead OTHER

Principal Investigators

  • Hamid Okhravi, MD · Eastern Virginia Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-02-26
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04436081 on ClinicalTrials.gov