Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013923
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2001-04-02
Brief Title:
Effectiveness of A Nutritional Brain Metabolic Enhancer for Alzheimer Disease
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
A Nutritional Brain Metabolic Enhancer for Alzheimer Disease
Status:
COMPLETED
Status Verified Date:
2003-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers disease
Detailed Description:
The ability of the brain to use its major fuel the sugar glucose is reduced in Alzheimers 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 Alzheimers 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 49 range 3 to 8 n 7 P 00004
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 12 hour before and 1 12 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
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 Alzheimers 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 49 range 3 to 8 n 7 P 00004
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 12 hour before and 1 12 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: