Dietary Supplementation with Anatabloc® in Alzheimer's Disease
The purpose of this study is to explore whether taking a version of the dietary supplement Anatabloc® exerts an effect on blood levels of amyloid beta (Aβ) or impacts global or functional measures of Alzheimer's disease in people with mild to moderate Alzheimer's. Outcomes for participants who take Anatabloc® lozenges two or three times per day will be compared with those of participants who take a placebo. The supplement is a naturally occurring, anti-inflammatory alkaloid.
|Minimum Age||Maximum Age||Gender||Healthy Volunteers|
|65 Years||90 Years||Both||No|
++Diagnosis of probable Alzheimer's disease, with or without a concurrent diagnosis of possible or probable vascular dementia ++Score 16 or more on the Mini-Mental State Examination (MMSE) ++Otherwise stable medical history and general health ++Weight of 45-120 kg (99-264 pounds) inclusive
++Contraindications, allergy, or sensitivity to the study products or their components ++Current smoker or smokeless tobacco user ++Prohibited medications: Systemic (oral or injectable) glucocorticoids; interferon-alpha; anti-CD20 antibody (e.g., rituximab); or anti-CTLA-4 antibody (e.g., ipilimumab)
Rock Creek Pharmaceuticals, Inc.
- Roskamp Institute, Inc.
|M. Varga, MD||Study Director||Star Scientific|
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® in Subjects with Alzheimer's Disease