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| Name | Class |
|---|---|
| Spier Family Foundation | UNKNOWN |
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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 individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high CBD/low THC sublingual solution | Drug | Hemp derived solution to be administered sublingually twice daily. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Total score of Cohen-Mansfield Inventory (CMAI) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Staci Gruber, PhD | Mclean Hospital | Principal Investigator |
| Ipsit V Vahia, MD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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This is an open label trial; all participants will receive active drug.
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| 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 |
Exploratory measure to see reduction in agitation symptoms
| Continuous, weeks 0-8 |
| Total Score of Zarit Caregiver Burden Interview | Exploratory downstream reduction in caregiver burden | Continuous, weeks 0-8 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D001008 | Anxiety Disorders |
| D011595 | Psychomotor Agitation |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003072 | Cognition Disorders |
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