Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
- Conditions
- Alzheimer DiseaseAnxietyAgitation,PsychomotorMild Cognitive Impairment (MCI) Due to Alzheimer's Disease
- Interventions
- Drug: high CBD/low THC sublingual solution
- Registration Number
- NCT04075435
- Lead Sponsor
- Mclean Hospital
- 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 cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All subjects high CBD/low THC sublingual solution This arm will include all subjects, individuals will administer a high CBD, low THC full spectrum sublingual solution twice daily on a variable dosing schedule.
- Primary Outcome Measures
Name Time Method Total of clinician impression column on anxiety domain of the NPI-C Continuous, weeks 0-8 Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale
- Secondary Outcome Measures
Name Time Method Week 8 MMSE total score compared to baseline MMSE total score longitudinal: screening/baseline and week8 Secondary Outcome Measure of safety as defined by lack of treatment emergent cognitive impairment as measured by the Mini Mental Status Exam (MMSE)
Score on the confusion assessment method Continuous screening weeks 0-8, dichotomous Secondary Outcome Measure of safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM)
Total score on the Generalized Anxiety Disorder 7 scale Continuous, week 0-8 Secondary Outcome Measure of anxiety reduction
Number of serious adverse events Continuous, weeks 0-8 Secondary Outcome Measure of safety defined by absence of serious adverse events
Number and severity of side effects reported Continuous, weeks 0-8 Secondary Outcome Measure of safety defined as a low number of emergent somatic side effects as measured by the Medication Side Effects Questionnaire
Trial Locations
- Locations (1)
McLean Hospital
🇺🇸Belmont, Massachusetts, United States