Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive… (NCT04075435) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
United States12 participantsStarted 2021-01-11
Plain-language 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).
Who can participate
Age range55 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Total of clinician impression column on anxiety domain of the NPI-C