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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.

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dietary Supplement: Anatabloc(R) Dietary Supplement: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Measured changes in blood markers of AD [ Time Frame: 3 months ]
    Changes in blood levels of amyloid beta (Aβ)

  2. 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



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Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01669876     History of Changes
Other Study ID Numbers: RCP-009
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015

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
Neurocognitive Disorders
Mental Disorders