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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Virginia Medical School
• Collaborators: Ananda Hemp, Inc.; Old Dominion University

Criteria

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.