Recruiting
Phase 2

CBD Oil

Sponsor:

Eastern Virginia Medical School

Code:

NCT04436081

Conditions

Alzheimer Disease

Dementia

Major Neurocognitive Disorder With Aggressive Behavior

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

THC-free CBD Oil

Placebo

Study Details

Brief 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

Study ID

NCT04436081

Start date

Feb 26, 2021

Status verified date

Feb, 2023

Completion date

Mar, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males/females over 50 years old.
  • Have a diagnosis of dementia due to AD or mixed AD with another type of dementia.
  • A Mini-Mental State Exam score (MMSE) between 4 and 28 inclusive.
  • Presence of agitation with a Neuropsychiatric Inventory (NPI)-agitation/aggression subscore > 3.
  • Participants and their informal caregivers must be fluent in English (includes reading, writing, and speech) and able to give informed consent.
  • For patients treated with cognitive-enhancing medications (cholinesterase inhibitors (ChEI) and/or memantine), the dosage must be stable for at least 1 month (30 days). If the ChEI and/or memantine has been discontinued, patients may enroll after 15 days.
  • Eligible caregivers must either live with the participant or have a minimum of 4 hours of daily contact with them.

Exclusion Criteria:

  • Diagnosis of non-AD or non-mixed dementias.
  • Very mild dementia or advanced dementia (MMSE: greater than 28 or less than 4).
  • NPI-agitation-aggression score < 3.
  • Having a serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease which might confound assessment of safety outcomes as determined by the study physician.
  • Presence or history of other serious psychiatric disorders or neurological conditions (e.g. psychotic disorders, bipolar disorder or schizophrenia).
  • Current abuse of/dependence on marijuana, current drug abuse, current alcohol abuse.
  • Having seizure disorders.
  • Pregnant or breastfeeding
  • Indication of baseline delirium as determined by the Confusion Assessment Method (CAM).
  • Current use of lithium.
  • Inability to swallow CBD oil softgels.
  • Changes in dosage of anti-depressives within 4 weeks before randomization and during the study.
  • Changes in dosage of antipsychotics or benzodiazepines within 1 week prior to randomization and during the study.
  • Contraindications to CBD oil (history of hypersensitivity to any cannabinoid).
  • Frequent falling due to orthostatic hypotension.
  • Use of tricyclic antidepressants (TCA), fluoxetine, and/or carbamazepine. -Patients who reside in nursing homes.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

THC-free CBD Oil

Hemp-based CBD oil Gelcaps

Placebo

Placebo Gelcaps

Primary outcome measure

  • Change in agitation and aggression. [ Time Frame: Every two weeks for 15 weeks during study enrollment. ]
  • Change in caregiver burden. [ Time Frame: Three times during the 15 weeks of study enrollment. ]
  • Change in the participant's quality of life. [ Time Frame: Three times during the 15 weeks of study enrollment. ]
  • Change in caregiver's quality of life. [ Time Frame: Three times during the 15 weeks of study enrollment. ]

Central Contacts and Locations

Central contacts

David Elkins, MS

757.446.5675ELKINSDE@evms.edu

Locations

Eastern Virginia Medical School

Recruiting

Norfolk, Virginia, United States, 23510

Contacts

Hamid Okhravi, MD

757-446-7040okhravHR@evms.edu

Principal Investigator:

Hamid Okhravi, MD

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

Feb 16, 2023

Last verified

Feb, 2023

Keywords

  • Agitation
  • Aggression
  • Neuropsychiatric symptoms
  • CBD Oil
  • Cannabinoids
  • Caregiver burden
  • Sleep quality
  • Behavioral and Psychological Symptoms of Dementia
  • Neurocognitive disorders
  • Psychomotor agitation
  • Cannabidiols

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2023-02-16.