Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 65 - 90 |
| Updated: | 5/3/2014 |
| Start Date: | August 2012 |
| End Date: | February 2015 |
| Contact: | A Cohen |
| Email: | acohen@rockcreekpharmaceuticals.com |
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
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.
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.
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.
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