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

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Eastern Virginia Medical School
Study ID
NCT04436081
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • THC-free CBD Oil — DRUG
    Hemp-based CBD oil Gelcaps
  • Placebo — DRUG
    Placebo Gelcaps

Study Details

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.

Key Dates

Start date
Feb 26, 2021
Status verified
Feb 2023
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Hemp-based CBD oil Gelcaps
    The intervention consists of 6 weeks oral administration of CBD oil Gelcaps, starting at a dosage of 15 mg twice per day with up titration to 45 mg twice per day. At any given dose, if participants develop side effects, the dosage will be reduced to the previous dose.
  • Placebo Comparator: Oral placebo Gelcaps
    Participants in the control group will receive oral placebo Gelcaps that are identical in appearance to the CBD oil Gelcaps. Dosing will be identical to the intervention arm.

Primary Outcome Measure

Change in agitation and aggression. [ Time Frame: Every two weeks for 15 weeks during study enrollment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eastern Virginia Medical SchoolNorfolkVirginia23510
Hamid Okhravi, MD
[email protected]
757-446-7040
Hamid Okhravi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Norfolk, VA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Eastern Virginia Medical School· Norfolk, VA

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