← Back to Search

Cannabinoid

THC-Free CBD Oil for Alzheimer's Disease

Phase 2

Recruiting

Led By Hamid Okhravi, MD

Research Sponsored by Eastern Virginia Medical School

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of dementia due to AD or mixed AD with another type of dementia

Males/females over 50 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three times during the 15 weeks of study enrollment.

Awards & highlights

Study Summary

This trial will test whether THC-free CBD oil can help reduce agitation and improve quality of life for people with Alzheimer's disease.

Who is the study for?

This trial is for people over 50 with Alzheimer's who experience agitation. They must have a certain score on a mental state exam, stable dementia medication use, and be in regular contact with their caregivers. Excluded are those pregnant, with severe psychiatric or neurological conditions, unstable illnesses, recent medication changes, drug or alcohol abuse issues.Check my eligibility

What is being tested?

The study tests if THC-free CBD oil can calm agitation in Alzheimer's patients compared to a placebo. It's randomized (participants are chosen by chance), double-blinded (neither researchers nor participants know who gets what treatment), and has two phases where each group will receive both the CBD oil and placebo at different times.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of CBD may include tiredness, diarrhea, changes in appetite/weight. Since it’s THC-free, it should not cause 'high' feelings or significant psychoactive effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Alzheimer's disease or a mix of Alzheimer's and another type of dementia.

Select...

I am over 50 years old.

Select...

My medication for cognitive enhancement has been stable for at least a month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three times during the 15 weeks of study enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three times during the 15 weeks of study enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and three times during the 15 weeks of study enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in agitation and aggression.

Change in caregiver burden.

Change in caregiver's quality of life.

+1 more

Secondary outcome measures

Assessment of change in cognitive skills.

Assessment of change in neuropsychiatric symptoms.

The effect of CBD oil on sleep quantity measured by Fitbit

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Hemp-based CBD oil GelcapsActive Control1 Intervention

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.

Group II: Oral placebo GelcapsPlacebo Group1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ananda Hemp, Inc.UNKNOWN

1 Previous Clinical Trials

56 Total Patients Enrolled

Old Dominion UniversityOTHER

20 Previous Clinical Trials

15,004 Total Patients Enrolled

Eastern Virginia Medical SchoolLead Sponsor

68 Previous Clinical Trials

10,363 Total Patients Enrolled

Media Library

THC-free CBD Oil (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04436081 — Phase 2

Dementia Research Study Groups: Hemp-based CBD oil Gelcaps, Oral placebo Gelcaps

Dementia Clinical Trial 2023: THC-free CBD Oil Highlights & Side Effects. Trial Name: NCT04436081 — Phase 2

THC-free CBD Oil (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04436081 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining slots for participants in this trial?

"Yes, the information on clinicaltrials.gov indicates that this research is seeking participants currently. This trial was first advertised on February 26th 2021 and has been modified as recently as May 2nd 2022. 40 individuals are being recruited from a single site for this endeavour."

Answered by AI

Has the FDA endorsed Hemp-based CBD oil Gelcaps?

"With prior safety data in the Phase 2 trial, Hemp-based CBD oil Gelcaps received a score of 2 on our team at Power's scale. Nonetheless, this product lacks clinical evidence to support efficacy."

Answered by AI

Could you enlighten me on the outcomes from prior studies utilizing Hemp-based CBD oil Gelcaps?

"Currently, 79 studies are in progress exploring the use of Hemp-based CBD oil Gelcaps. Of these trials, 16 are currently in their third phase. Most of the tests for this drug occur near Ribeirao Preto, Sao Paulo; however there exist 289 other locations running experiments on this medication."

Answered by AI

What are the eligibility requirements for participating in this clinical trial?

"This study is recruiting 40 individuals aged 50-90 that have been diagnosed with dementia, either from Alzheimer's disease or a mixture of AD and other types of dementia. Additional entry requirements include scoring between 4 to 28 on the MMSE test, showing signs of agitation as determined by their NPI-agitation/aggression subscore being higher than 3, and if they are taking cognitive enhancers such as ChEI or memantine then these dosages must be stable for at least 30 days prior to enrollment. Caregivers should also live within close proximity of the participant or possess an active relationship which entails no less than four hours daily"

Answered by AI

How many participants are undertaking this trial?

"Indeed, clinicaltrials.gov confirms that this medical trial has been actively recruiting since February 26th 2021 and is still seeking to enroll 40 patients at a single site as of May 2nd 2022."

Answered by AI