Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Alzheimer's Dementia

Study Overview
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Brief Summary
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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.

Official Title
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Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Alzheimer's Dementia

Conditions
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Alzheimer Disease, Anxiety, Agitation,Psychomotor

Intervention / Treatment
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* Drug: high CBD/low THC sublingual solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al. MMSE score of 15-24 (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 60-90 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 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open label trial; all participants will receive active drug.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All subjects<br>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<br>* Hemp derived solution to be administered sublingually twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score on the Generalized Anxiety Disorder 7 scale | Secondary Outcome Measure of anxiety reduction | Continuous, week 0-8 | 
| Number of serious adverse events | Secondary Outcome Measure of safety defined by absence of serious adverse events | Continuous, weeks 0-8 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cannabidiol, older adults