Effectiveness of A Nutritional Brain Metabolic Enhancer for Alzheimer Disease

This study has been completed.
Sponsor:
Collaborator:
Burke Medical Research Institute
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00013923
First received: April 2, 2001
Last updated: December 10, 2009
Last verified: August 2003
  Purpose

The purpose of this study is to evaluate the effectiveness of a nutritional supplement that has been developed to improve the brain function of a patient with Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
Drug: Nutritional Supplement
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Nutritional Brain Metabolic Enhancer for Alzheimer Disease

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 40
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Detailed Description:

The ability of the brain to use its major fuel, the sugar glucose, is reduced in Alzheimer's disease. A nutritional supplement has been developed to improve the function of the Alzheimer brain by increasing its ability to use sugar effectively. The ingredients of the supplement are natural products, and are found in the normal American diet. Results have been encouraging in open trials where the patients knew they were taking the active medicine. Patients are now being invited to participate in a placebo-controlled trial lasting 3 months, followed by a 3-month open label trial where all patients will receive the active preparation.

This is a double-blind, placebo-controlled, parallel-group, 3 month trial followed by a 3-month open-label period, of a nutritional supplement designed to improve brain metabolism and function in patients with Alzheimer's disease (AD). The design of the nutritional supplement is based on replicated observations of abnormalities in mitochondria in AD. The constituents of the nutritional supplement are components of the normal American diet, and are classified by the FDA as GRAS (Generally Regarded As Safe). Results with the supplement have been favorable in preliminary, open trials (eg mean improvement in MMSE score of +4.9, range +3 to +8, n = 7, P <0.0004).

During the placebo-controlled portion of the trial, half of the participants will receive the active preparation and half a sugar pill. During this first phase, neither the patients nor those testing them will know who is taking active medicine and who is taking placebo. The active supplement or placebo are taken as 1 tablespoon twice a day, between meals. If desired, the supplement or placebo can be stirred into, or washed down with, water, coffee or tea without milk or sugar, or the soft drink TAB. Patient visits to the Burke Medical Research Institute will be once a month, after the screening and baseline visits.

The supplement is taken as one tablespoon of a fluid, between meals. Since other sugars or citrate can be expected to interfere with the actions of the supplements, food or drinks containing sugar or citrate and diet drinks containing citrate are to be avoided for 1 1/2 hour before and 1 1/2 hour after taking the supplement. No significant adverse events have been associated with this supplement. However, standard precautions for patient safety are being taken, including medical examination and clinical laboratory tests at screening and at the completion of the double-blind and open-label phases.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria include:

  • A documented diagnosis of Alzheimer's disease;
  • MMSE score between 10 and 26 inclusive;
  • A reliable caregiver to ensure compliance.

Exclusion criteria include:

  • diabetes, unstable medical illness, myocardial infarction or cancer diagnosed within the previous 12 months, or treatment with systemic steroids.
  • Patients being treated for depression or other psychiatric symptomatology are eligible, if their symptoms are under control on a stable dose of medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013923

Locations
United States, New York
Burke Medical Research Institute
White Plains, New York, United States, 10605
Sponsors and Collaborators
Burke Medical Research Institute
Investigators
Principal Investigator: John P Blass, MD, PhD Burke Medical Research Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00013923     History of Changes
Other Study ID Numbers: IA0027
Study First Received: April 2, 2001
Last Updated: December 10, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Nutritional Supplement

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014