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

This study has suspended participant recruitment.
(Pending clarification of the administrative status of active ingredient anatabine)
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: March 5, 2014
Last verified: March 2014
  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:


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 2015
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Roskamp Institute
Sarasota, Florida, United States, 34243
Sponsors and Collaborators
Rock Creek Pharmaceuticals, Inc.
Roskamp Institute Inc.
Investigators
Principal Investigator: A Keegan, MD Roskamp Institute
  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: March 5, 2014
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 August 28, 2014