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Trial NCT00013923

Resource URI: http://static.linkedct.org/resource/trials/NCT00013923
linkedct:brief_title Effectiveness of A Nutritional Brain Metabolic Enhancer for Alzheimer Disease
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/979>
linkedct:condition <http://static.linkedct.org/resource/condition/829>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 50 Years
linkedct:end_date June 2005
linkedct:enrollment 40 (xsd:int)
linkedct:firstreceived_date April 2, 2001
linkedct:id NCT00013923
rdfs:label Trial NCT00013923
linkedct:lastchanged_date December 10, 2009
linkedct:lead_sponsor_agency National Institute on Aging (NIA)
linkedct:location <http://static.linkedct.org/resource/location/154764>
linkedct:nct_id NCT00013923
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Nutritional Brain Metabolic Enhancer for Alzheimer Disease
linkedct:org_study_id IA0027
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/29248>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00013923>
linkedct:phase Phase 2
linkedct:primary_completion_date June 2005
linkedct:reference <http://static.linkedct.org/resource/reference/48233>
linkedct:reference <http://static.linkedct.org/resource/reference/7184>
linkedct:reference <http://static.linkedct.org/resource/reference/9260>
linkedct:source National Institute on Aging (NIA)
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date August 2003