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

Primary Purpose

Alzheimer Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anatabloc(R)
Placebo
Sponsored by
Rock Creek Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Randomized, Double-Blind, Dietary Supplements

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Roskamp Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dietary Supplement: Anatabloc(R)

Placebo

Arm Description

Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day

Placebo, as mint-flavored lozenge, to be taken 2-3 times each day

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Measured changes in blood markers of AD
Changes in blood levels of amyloid beta (Aβ)
Changes in global or functional measures of AD in subjects during the course of the study
Changes in subject's scores in global and functional measures of AD during the course of the study

Full Information

First Posted
August 17, 2012
Last Updated
April 28, 2015
Sponsor
Rock Creek Pharmaceuticals, Inc.
Collaborators
Roskamp Institute Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01669876
Brief Title
Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease
Acronym
ASAP
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Administrative status of active ingredient anatabine
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rock Creek Pharmaceuticals, Inc.
Collaborators
Roskamp Institute Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Randomized, Double-Blind, Dietary Supplements

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Supplement: Anatabloc(R)
Arm Type
Active Comparator
Arm Description
Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, as mint-flavored lozenge, to be taken 2-3 times each day
Intervention Type
Dietary Supplement
Intervention Name(s)
Anatabloc(R)
Intervention Description
Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo, as a mint-flavored lozenge, to be taken 2-3 times each day
Primary Outcome Measure Information:
Title
Number of subjects experiencing adverse effects when using the supplement
Description
Collected data on the numbers and types of adverse effects among subject individuals with mild to moderate Alzheimer's disease (AD).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Measured changes in blood markers of AD
Description
Changes in blood levels of amyloid beta (Aβ)
Time Frame
3 months
Title
Changes in global or functional measures of AD in subjects during the course of the study
Description
Changes in subject's scores in global and functional measures of AD during the course of the study
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Keegan, MD
Organizational Affiliation
Roskamp Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roskamp Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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