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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04075435
Other study ID # 2019P002466
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 11, 2021
Est. completion date September 15, 2024

Study information

Verified date March 2024
Source Mclean Hospital
Contact Rosain C Ozonsi, BS
Phone 617-855-2511
Email rozonsi@mclean.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date September 15, 2024
Est. primary completion date September 15, 2024
Accepts healthy volunteers No
Gender All
Age group 55 Years to 90 Years
Eligibility Inclusion Criteria: 1. Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI 2. MMSE score of 15-30 (inclusive) 3. Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of =4 on the Anxiety domain of the NPI-C 4. A health care proxy available to sign consent on behalf of the participant (if applicable) 5. A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits 6. Participants and their study partner must be fluent in English 7. Must be 60-90 years old (inclusive) Exclusion Criteria: 1. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes. 2. Seizure disorder 3. Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI 4. Current episode of major depression, as determined by the MINI 5. Active substance abuse or dependence within the past 6 months, as determined by the MINI 6. Delirium (as measured by the CAM) 7. Current inpatient hospitalization 8. Current regular use of cannabinoid products (>1 use per month) 9. Positive urine screen for THC at the screening or baseline visit 10. Allergy to coconut 11. 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


Intervention

Drug:
high CBD/low THC sublingual solution
Hemp derived solution to be administered sublingually twice daily.

Locations

Country Name City State
United States McLean Hospital Belmont Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Mclean Hospital Spier Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Total clinical impression column score on neuropsychiatric inventory agitation and aggression domains (NPI-C) Exploratory measure to see reduction in agitation and aggression symptoms Continuous, weeks 0-8
Other Total score of Cohen-Mansfield Inventory (CMAI) Exploratory measure to see reduction in agitation symptoms Continuous, weeks 0-8
Other Total Score of Zarit Caregiver Burden Interview Exploratory downstream reduction in caregiver burden Continuous, weeks 0-8
Other Stability of anxiety and agitation reduction using anxiety domain of NPI-C and GAD-7 Exploratory investigation into the stability of anxiety reduction using the anxiety domain score on the NPI-C and the GAD-7 during the optional follow-up phase Months 3, 6, 9, and 12 of the optional follow-up phase
Other Stability of caregiver burden reduction Exploratory investigation into reduction of caregiver burden using the Zarit Caregiver Burden Interview during the optional follow-up phase Months 3, 6, 9, and 12 of the optional follow-up phase
Primary Total of clinician impression column on anxiety domain of the NPI-C Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale Continuous, weeks 0-8
Secondary Total score on the Generalized Anxiety Disorder 7 scale Secondary Outcome Measure of anxiety reduction Continuous, week 0-8
Secondary Number of serious adverse events Secondary Outcome Measure of safety defined by absence of serious adverse events Continuous, weeks 0-8
Secondary 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) longitudinal: screening/baseline and week8
Secondary 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) Continuous screening weeks 0-8, dichotomous
Secondary 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 Continuous, weeks 0-8
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