Dietary Supplementation with Anatabloc® in Alzheimer's Disease
Dietary Supplementation with Anatabloc® in Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
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.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
65 Years | 90 Years | Both | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Detailed Description:
None provided.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 27.4081935, -82.5294065 | Sarasota | Florida | 34243 | Recruiting | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
Rock Creek Pharmaceuticals, Inc. |
Collaborator Sponsor:
| Agency |
|---|
Roskamp Institute, Inc. |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
M. Varga, MD | Study Director | Star Scientific |
Study Contact:
| Name | |
|---|---|
A. Cohen |
Locations
ClinicalTrials.gov ID
NCT01669876 (follow link to view full record on ct.gov in new window)
Official Title:
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
Study Start Date:
August 2012
Study End Date:
November 2013
Disease Stage:
Early
Middle
Enrollment:
200
