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

Launched by EASTERN VIRGINIA MEDICAL SCHOOL · Jun 16, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of THC-free CBD oil on reducing agitation in people with Alzheimer’s disease. Agitation can include symptoms like restlessness, aggression, or anxiety, which can be challenging for both patients and their caregivers. The researchers want to find out if the CBD oil can help lessen these symptoms and improve the quality of life for patients, as well as make caregiving easier.

To participate, individuals must be over 50 years old and have a diagnosis of dementia related to Alzheimer’s. They should also experience noticeable agitation, as measured by a specific scale. Participants must have a stable treatment plan if they are on certain medications, and they need to be fluent in English. The trial is currently looking for volunteers, and those who join can expect to either receive the CBD oil or a placebo (a treatment with no active ingredients) during different phases of the study. It’s important to note that individuals with serious medical conditions or certain psychiatric disorders, among other criteria, may not be eligible for this trial.

Gender

ALL

Eligibility 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.