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

This study is currently recruiting participants.
Verified May 2013 by Rock Creek Pharmaceuticals, Inc.
Sponsor:
Collaborator:
Roskamp Institute Inc.
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01669876
First received: August 17, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
 Dietary Supplement: Anatabloc(R)
Dietary Supplement: Placebo
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rock Creek Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Number of subjects experiencing adverse effects when using the supplement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Collected data on the numbers and types of adverse effects among subject individuals with mild to moderate Alzheimer's disease (AD).


Secondary Outcome Measures:
  • Measured changes in blood markers of AD [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Changes in blood levels of amyloid beta (Aβ)

  • Changes in global or functional measures of AD in subjects during the course of the study [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Changes in subject's scores in global and functional measures of AD during the course of the study


Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dietary Supplement: Anatabloc(R)
Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day
 Dietary Supplement: Anatabloc(R)
Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day
Placebo Comparator: Placebo
Placebo, as mint-flavored lozenge, to be taken 2-3 times each day
 Dietary Supplement: Placebo
Placebo, as a mint-flavored lozenge, to be taken 2-3 times each day

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669876

Contacts
Contact: A Cohen acohen@rockcreekpharmaceuticals.com

Locations
United States, Florida
Roskamp Institute Recruiting
Sarasota, Florida, United States, 34243
Contact: C Rindfleisch     941-256-8018 ext 353     crindfleisch@roskampinstitute.net    
Principal Investigator: A Keegan, MD            
Sponsors and Collaborators
Rock Creek Pharmaceuticals, Inc.
Roskamp Institute Inc.
Investigators
Study Director: M Varga, MD Star Scientific
  More Information

No publications provided

Responsible Party: Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01669876     History of Changes
Other Study ID Numbers: RCP-009
Study First Received: August 17, 2012
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rock Creek Pharmaceuticals, Inc.:
Randomized
Double-Blind
Dietary Supplements

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013