CBD: Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Alzheimer's Dementia
Study Details
Study Description
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 mild to moderate Alzheimer's Disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: All subjects 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. |
Drug: high CBD/low THC sublingual solution
Hemp derived solution to be administered sublingually twice daily.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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)
- 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
Other Outcome Measures
- Total clinical impression column score on neuropsychiatric inventory agitation and aggression domains (NPI-C) [Continuous, weeks 0-8]
Exploratory measure to see reduction in agitation and aggression symptoms
- Total score of Cohen-Mansfield Inventory (CMAI) [Continuous, weeks 0-8]
Exploratory measure to see reduction in agitation symptoms
- Total Score of Zarit Caregiver Burden Interview [Continuous, weeks 0-8]
Exploratory downstream reduction in caregiver burden
- Stability of anxiety and agitation reduction using anxiety domain of NPI-C and GAD-7 [Months 3, 6, 9, and 12 of the optional follow-up phase]
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
- Stability of caregiver burden reduction [Months 3, 6, 9, and 12 of the optional follow-up phase]
Exploratory investigation into reduction of caregiver burden using the Zarit Caregiver Burden Interview during the optional follow-up phase
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al.
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MMSE score of 15-24 (inclusive)
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Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of ≥4 on the Anxiety domain of the NPI-C
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A health care proxy available to sign consent on behalf of the participant (if applicable)
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A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits
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Participants and their study partner must be fluent in English
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Must be 60-90 years old (inclusive)
Exclusion Criteria:
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Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.
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Seizure disorder
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Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI
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Current episode of major depression, as determined by the MINI
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Active substance abuse or dependence within the past 6 months, as determined by the MINI
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Delirium (as measured by the CAM)
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Current inpatient hospitalization
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Current regular use of cannabinoid products (>1 use per month)
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Positive urine screen for THC at the screening or baseline visit
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Allergy to coconut
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McLean Hospital | Belmont | Massachusetts | United States | 02478 |
Sponsors and Collaborators
- Mclean Hospital
- Spier Family Foundation
Investigators
- Principal Investigator: Brent P Forester, MD, MSc, Mclean Hospital
- Principal Investigator: Staci Gruber, PhD, Mclean Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019P002466