Effectiveness of A Nutritional Brain Metabolic Enhancer for Alzheimer Disease
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nutritional Supplement
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Nutritional Supplement
Eligibility 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
Sites / Locations
- Burke Medical Research Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00013923
First Posted
April 2, 2001
Last Updated
December 10, 2009
Sponsor
National Institute on Aging (NIA)
Collaborators
Burke Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00013923
Brief Title
Effectiveness of A Nutritional Brain Metabolic Enhancer for Alzheimer Disease
Official Title
A Nutritional Brain Metabolic Enhancer for Alzheimer Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Aging (NIA)
Collaborators
Burke Medical Research Institute
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Nutritional Supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nutritional Supplement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Blass, MD, PhD
Organizational Affiliation
Burke Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burke Medical Research Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11193795
Citation
Blass JP. The mitochondrial spiral. An adequate cause of dementia in the Alzheimer's syndrome. Ann N Y Acad Sci. 2000;924:170-83. doi: 10.1111/j.1749-6632.2000.tb05576.x.
Results Reference
background
PubMed Identifier
10818509
Citation
Blass JP, Sheu RK, Gibson GE. Inherent abnormalities in energy metabolism in Alzheimer disease. Interaction with cerebrovascular compromise. Ann N Y Acad Sci. 2000 Apr;903:204-21. doi: 10.1111/j.1749-6632.2000.tb06370.x.
Results Reference
background
PubMed Identifier
8295654
Citation
Manning CA, Ragozzino ME, Gold PE. Glucose enhancement of memory in patients with probable senile dementia of the Alzheimer's type. Neurobiol Aging. 1993 Nov-Dec;14(6):523-8. doi: 10.1016/0197-4580(93)90034-9.
Results Reference
background
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Effectiveness of A Nutritional Brain Metabolic Enhancer for Alzheimer Disease
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