Alzheimer's Disease Education and Referral Center

Dietary Supplementation with Anatabloc® in Alzheimer's Disease

Dietary Supplementation with Anatabloc® in Alzheimer's Disease

Overall Status: 
Suspended
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 AgeMax AgeGenderHealthy 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 CityStateZip CodeStatusPrimary Contact

Geolocation is 27.4081935, -82.5294065

Site
Sarasota
Florida
34243
Name:
Phone:
Lead Sponsor: 
Agency
Rock Creek Pharmaceuticals, Inc.
Collaborator Sponsor: 
Agency
Roskamp Institute, Inc.
Facility Investigators: 
NameRoleAffiliation
M. Varga, MD
Study Director
Star Scientific
Study Contact: 
Locations
 
 
ClinicalTrials.gov ID 
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: 
February 2014
Disease Stage: 
Early
Middle
Enrollment: 
200