Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Official Title
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3-Month, Single Site or Multi-Site, Double Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety Tolerability and Potential Effects of the Dietary Supplement Anatabloc(R) in Subjects With Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Dietary Supplement: Anatabloc(R)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 65 years old. Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible or probable vascular dementia. Score 16 or more on the Mini-Mental State Examination (MMSE). Otherwise stable medical history and general health. Weigh between 45 kg and 120 kg inclusive. Exclusion Criteria: Have contra-indications, allergy, or sensitivity to the study products or their components. Be currently taking any of the following medications: systemic (oral or injectable) glucocorticoids; interferon-alpha; anti-CD20 antibody (e.g., rituximab); or anti-CTLA-4 antibody (e.g., ipilimumab). Be a current smoker or smokeless tobacco user.

Ages Eligible for Study
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Minimum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary Supplement: Anatabloc(R)<br>Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day | Dietary Supplement: Anatabloc(R)<br>* Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day<br>|
| Placebo Comparator: Placebo<br>Placebo, as mint-flavored lozenge, to be taken 2-3 times each day | Dietary Supplement: Placebo<br>* Placebo, as a mint-flavored lozenge, to be taken 2-3 times each day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double-Blind, Randomized, Dietary Supplements