THC-free CBD oil to reduce agitation in Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, crossover Phase 2 trial comparing THC-free cannabidiol (CBD) oil with placebo in people with Alzheimer's disease or mixed dementia who have clinically significant agitation. Eligible participants are adults over 50 with an MMSE between 4 and 28 and an NPI agitation/aggression subscore greater than 3, and must have an informal caregiver with regular daily contact. The study measures changes in agitation severity, caregiver burden, and participant quality of life across treatment and placebo periods. Participants and caregivers must be fluent in English and able to attend study visits at the lead site.

Why it matters

Who can join: the full rules

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.

Where it's running

• Eastern Virginia Medical School
  Norfolk, Virginia, United States Recruiting

Study contacts

• Principal investigator: Hamid Okhravi, MD — Eastern Virginia Medical School
• Study coordinator: David Elkins, MS
• Email: ELKINSDE@evms.edu
• Phone: 757.446.5675

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.