Brief Summary

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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"

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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Study Primary Completion Date: December 2013

Interventions Used in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

• Number of subjects experiencing adverse effects when using the supplement
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• Measured changes in blood markers of AD
  • Time Frame: 3 months
    Safety Issue?: No
• Changes in global or functional measures of AD in subjects during the course of the study
  • Time Frame: 3 months
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Rock Creek Pharmaceuticals, Inc.
• Collaborator
  • Roskamp Institute Inc.
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • M Varga, MD, Study Director, Star Scientific
• Overall Contact(s)
  • A Cohen, acohen@rockcreekpharmaceuticals.com