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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Short Term Efficacy and Safety of Perispinal Administration of Etanercept in Mild to Moderate Alzheimer's Disease

NCT01716637

Alzheimer's Disease

COMPLETED PHASE1

Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD

NCT04500847

Alzheimer Disease, Early Onset Mild Cognitive Impairment Moderate Dementia

RECRUITING PHASE1

Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment

NCT02573740

Alzheimer's Disease Mild Cognitive Impairment

TERMINATED PHASE1

Effects of Mitochondrial-targeted Antioxidant on Mild Cognitive Impairment (MCI) Patients

NCT03514875

Alzheimer Disease, Early Onset Mild Cognitive Impairment

WITHDRAWN NA

Anti-Oxidant Treatment of Alzheimer's Disease

NCT00117403

Alzheimer's Disease

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dietary Supplement: Anatabloc(R)

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

Group Type ACTIVE_COMPARATOR

Anatabloc(R)

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anatabloc(R)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No