Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al.
MMSE score of 15-24 (inclusive)
Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of ≥4 on the Anxiety domain of the NPI-C
A health care proxy available to sign consent on behalf of the participant (if applicable)
A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits
Participants and their study partner must be fluent in English
Must be 60-90 years old (inclusive)

Exclusion Criteria:

Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.
Seizure disorder
Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI
Current episode of major depression, as determined by the MINI
Active substance abuse or dependence within the past 6 months, as determined by the MINI
Delirium (as measured by the CAM)
Current inpatient hospitalization
Current regular use of cannabinoid products (>1 use per month)
Positive urine screen for THC at the screening or baseline visit
Allergy to coconut
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