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A Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease

NCT01320527 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2016-03-03

No results posted yet for this study

Summary

Based on prior published pilot studies, the investigators have initiated a larger, multi-site placebo-controlled clinical trial with Alzheimer's disease (AD) patients and individuals diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming (or denying) the above promising clinical findings, and (2) determining whether or not our formulation can delay MCI "conversion" to AD.

Conditions

Interventions

DIETARY_SUPPLEMENT

Nutriceutical formulation

Two pills that collectively contain: folic acid (400µg), Vitamin B12 (6µg), Vitamin E (as alpha-tocopherol; 30 IU), S-adenosylmethionine (SAM; 400mg), N-acetyl cysteine (NAC; 600mg) and Acetyl-L-carnitine (ALCAR; 500mg). Taken once daily for duration of study (1 year).

OTHER

Placebo

A mixture of 6 vitamins and nutriceuticals

Sponsors & Collaborators

  • University of Massachusetts, Lowell

    collaborator OTHER

  • Alzheimer's Association

    collaborator OTHER

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Ruth Remington, Ph.D. · UMass Lowell, Lowell, MA 01854

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320527 on ClinicalTrials.gov