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

Eligibility 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)
• 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