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

Phase 2

Terminated

• Conditions: Alzheimer Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Anatabloc(R)

• Registration Number: NCT01669876
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-21
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, as mint-flavored lozenge, to be taken 2-3 times each day
Dietary Supplement: Anatabloc(R)	Anatabloc(R)	Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day

Primary Outcome Measures

Name	Time	Method
Number of subjects experiencing adverse effects when using the supplement	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

Name	Time	Method
Measured changes in blood markers of AD	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	3 months	Changes in subject's scores in global and functional measures of AD during the course of the study

Trial Locations

Locations (1)

Roskamp Institute; 🇺🇸 Sarasota, Florida, United States