Overview

Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Alzheimer's Dementia

Status:
Recruiting
Trial end date:
2022-01-11
Target enrollment:
0
Participant gender:
All
Summary
This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in mild to moderate Alzheimer's Disease.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mclean Hospital
Collaborator:
Spier Family Foundation
Treatments:
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

1. Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al.

2. MMSE score of 15-24 (inclusive)

3. Clinically significant degree of anxiety, as defined by a Clinical Impression total
column score of ≥4 on the Anxiety domain of the NPI-C

4. A health care proxy available to sign consent on behalf of the participant (if
applicable)

5. A caregiver who spends at least 10 hours per week with the subject who is able to
attend all study visits

6. Participants and their study partner must be fluent in English

7. Must be 60-90 years old (inclusive)

Exclusion Criteria:

1. Serious or unstable medical illness, including cardiovascular, hepatic, renal,
respiratory, endocrine, neurologic or hematologic disease, which might confound
assessment of safety outcomes.

2. Seizure disorder

3. Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as
determined by the MINI

4. Current episode of major depression, as determined by the MINI

5. Active substance abuse or dependence within the past 6 months, as determined by the
MINI

6. Delirium (as measured by the CAM)

7. Current inpatient hospitalization

8. Current regular use of cannabinoid products (>1 use per month)

9. Positive urine screen for THC at the screening or baseline visit

10. Allergy to coconut

11. Participants taking strong inhibitors or inducers of CYP3A4 (e.g. fluconazole,
fluoxetine, fluvoxamine, ticlopidine, St. John's Wort, etc.), CYP2C19 (ketoconazole,
erythromycin, etc.), or anti-epileptic drugs