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Administrative status of active ingredient anatabine
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| Name | Class |
|---|---|
| Roskamp Institute Inc. | OTHER |
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To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's Disease (AD) in subjects with mild to moderate AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement: Anatabloc(R) | Active Comparator | Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day |
|
| Placebo | Placebo Comparator | Placebo, as mint-flavored lozenge, to be taken 2-3 times each day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anatabloc(R) | Dietary Supplement | Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects experiencing adverse effects when using the supplement | Collected data on the numbers and types of adverse effects among subject individuals with mild to moderate Alzheimer's disease (AD). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measured changes in blood markers of AD | Changes in blood levels of amyloid beta (Aβ) | 3 months |
| Changes in global or functional measures of AD in subjects during the course of the study | Changes in subject's scores in global and functional measures of AD during the course of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A Keegan, MD | Roskamp Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roskamp Institute | Sarasota | Florida | 34243 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo | Dietary Supplement | Placebo, as a mint-flavored lozenge, to be taken 2-3 times each day |
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| 3 months |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |