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

Inclusion criteria

• Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI
• MMSE score of 15-30 (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 55-90 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