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

Alzheimer Disease Clinical Trial

— ASAP  

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(R) in Subjects With Alzheimer's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01669876
• Other study ID #: RCP-009
• Status: Terminated
• Phase: Phase 2
• First received: August 17, 2012
• Last updated: April 28, 2015
• Start date: August 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Rock Creek Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Dietary Supplement:
• Anatabloc(R)
Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day
• Placebo
Placebo, as a mint-flavored lozenge, to be taken 2-3 times each day

Locations

Country	Name	City	State
United States	Roskamp Institute	Sarasota	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Rock Creek Pharmaceuticals, Inc.	Roskamp Institute Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measured changes in blood markers of AD	Changes in blood levels of amyloid beta (Aß)	3 months	No
Secondary	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	No