Agitation,Psychomotor, Alzheimer Disease, Anxiety, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Conditions
Keywords
cannabidiol, older adults, dementia
Brief 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 individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
Interventions
DRUGhigh CBD/low THC sublingual solution
Hemp derived solution to be administered sublingually twice daily.
Sponsors
Mclean Hospital
Spier Family Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open label trial; all participants will receive active drug.
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI 2. MMSE score of 15-30 (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 55-90 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total of clinician impression column on anxiety domain of the NPI-C | Continuous, weeks 0-8 | Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total score on the Generalized Anxiety Disorder 7 scale | Continuous, week 0-8 | Secondary Outcome Measure of anxiety reduction |
| Number of serious adverse events | Continuous, weeks 0-8 | Secondary Outcome Measure of safety defined by absence of serious adverse events |
| Week 8 MMSE total score compared to baseline MMSE total score | longitudinal: screening/baseline and week8 | Secondary Outcome Measure of safety as defined by lack of treatment emergent cognitive impairment as measured by the Mini Mental Status Exam (MMSE) |
| Score on the confusion assessment method | Continuous screening weeks 0-8, dichotomous | Secondary Outcome Measure of safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM) |
| Number and severity of side effects reported | Continuous, weeks 0-8 | Secondary Outcome Measure of safety defined as a low number of emergent somatic side effects as measured by the Medication Side Effects Questionnaire |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStaci Gruber, PhD
Mclean Hospital
PRINCIPAL_INVESTIGATORIpsit V Vahia, MD
Mclean Hospital
Outcome results
None listed