Study Stopped
Administrative status of active ingredient anatabine
Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease
ASAP
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
1 other identifier
interventional
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 alzheimer-disease
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 17, 2012
CompletedFirst Posted
Study publicly available on registry
August 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedApril 30, 2015
April 1, 2015
2.3 years
August 17, 2012
April 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects experiencing adverse effects when using the supplement
Collected data on the numbers and types of adverse effects among subject individuals with mild to moderate Alzheimer's disease (AD).
3 months
Secondary Outcomes (2)
Measured changes in blood markers of AD
3 months
Changes in global or functional measures of AD in subjects during the course of the study
3 months
Study Arms (2)
Dietary Supplement: Anatabloc(R)
ACTIVE COMPARATORStudy product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day
Placebo
PLACEBO COMPARATORPlacebo, as mint-flavored lozenge, to be taken 2-3 times each day
Interventions
Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rock Creek Pharmaceuticals, Inc.lead
- Roskamp Institute Inc.collaborator
Study Sites (1)
Roskamp Institute
Sarasota, Florida, 34243, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A Keegan, MD
Roskamp Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2012
First Posted
August 21, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2014
Study Completion
February 1, 2015
Last Updated
April 30, 2015
Record last verified: 2015-04