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

Phase 2TerminatedNCT01669876

Rock Creek Pharmaceuticals, Inc.85 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alzheimer Disease

Interventions

Anatabloc(R)DIETARY_SUPPLEMENT

Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 65 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Roskamp Institute

Sarasota, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: 3 months

Secondary Outcomes

Measured changes in blood markers of AD

Changes in blood levels of amyloid beta (Aβ)

Time frame: 3 months

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

Time frame: 3 months

Data from ClinicalTrials.gov

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