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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Hemp derived solution to be administered sublingually twice daily.
McLean Hospital
Belmont, Massachusetts, United States
Total of clinician impression column on anxiety domain of the NPI-C
Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale
Time frame: Continuous, weeks 0-8
Total score on the Generalized Anxiety Disorder 7 scale
Secondary Outcome Measure of anxiety reduction
Time frame: Continuous, week 0-8
Number of serious adverse events
Secondary Outcome Measure of safety defined by absence of serious adverse events
Time frame: Continuous, weeks 0-8
Week 8 MMSE total score compared to baseline MMSE total score
Secondary Outcome Measure of safety as defined by lack of treatment emergent cognitive impairment as measured by the Mini Mental Status Exam (MMSE)
Time frame: longitudinal: screening/baseline and week8
Score on the confusion assessment method
Secondary Outcome Measure of safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM)
Time frame: Continuous screening weeks 0-8, dichotomous
Number and severity of side effects reported
Secondary Outcome Measure of safety defined as a low number of emergent somatic side effects as measured by the Medication Side Effects Questionnaire
Time frame: Continuous, weeks 0-8
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