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

August 17, 2012
March 5, 2014
August 2012
December 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01669876 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • Dietary Supplement: Anatabloc(R)
    Dietary supplement Anatabloc(R), as a 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
  • 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
    Intervention: Dietary Supplement: Anatabloc(R)
  • Placebo Comparator: Placebo
    Placebo, as mint-flavored lozenge, to be taken 2-3 times each day
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
200
February 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
65 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01669876
RCP-009
No
Rock Creek Pharmaceuticals, Inc.
Rock Creek Pharmaceuticals, Inc.
Roskamp Institute Inc.
Principal Investigator: A Keegan, MD Roskamp Institute
Rock Creek Pharmaceuticals, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP