Status:
RECRUITING
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Spier Family Foundation
Conditions:
Alzheimer Disease
Anxiety
Eligibility:
All Genders
55-90 years
Phase:
EARLY_PHASE1
Brief 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 cogni...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 16 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04075435
Start Date
January 11 2021
End Date
January 16 2026
Last Update
May 8 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478