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

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ClinicalTrials.gov Identifier: NCT01669876
Recruitment Status : Terminated (Administrative status of active ingredient anatabine)
First Posted : August 21, 2012
Last Update Posted : April 30, 2015
Sponsor:
Collaborator:
Roskamp Institute Inc.
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE August 17, 2012
First Posted Date  ICMJE August 21, 2012
Last Update Posted Date April 30, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
Number of subjects experiencing adverse effects when using the supplement [ Time Frame: 3 months ]
Collected data on the numbers and types of adverse effects among subject individuals with mild to moderate Alzheimer's disease (AD).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
  • Measured changes in blood markers of AD [ Time Frame: 3 months ]
    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 ]
    Changes in subject's scores in global and functional measures of AD during the course of the study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 28, 2015)
85
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2012)
200
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01669876
Other Study ID Numbers  ICMJE RCP-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rock Creek Pharmaceuticals, Inc.
Study Sponsor  ICMJE Rock Creek Pharmaceuticals, Inc.
Collaborators  ICMJE Roskamp Institute Inc.
Investigators  ICMJE
Principal Investigator: A Keegan, MD Roskamp Institute
PRS Account Rock Creek Pharmaceuticals, Inc.
Verification Date April 2015

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