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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01669876

Acronym

ASAP

Enrollment

Registered

2012-08-21

Start date

2012-08-31

Completion date

2015-02-28

Last updated

2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Randomized, Double-Blind, Dietary Supplements

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.

Interventions

DIETARY_SUPPLEMENTAnatabloc(R)

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

DIETARY_SUPPLEMENTPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026