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Sponsors and Collaborators: |
Rush University Medical Center Pamlab, L.L.C. |
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Information provided by: | Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT00597376 |
The purpose of this six-month research study is to determine if Cerefolin NAC reduces levels of substances in the blood that may be associated with thinking ability and the health of brain cells in subjects with memory concerns when compared to a standard multivitamin. Cerefolin NAC is available as a dietary supplement via a prescription from a physician. The multivitamin used in the study contains the Recommended Daily Intake recommended for older persons.
Condition | Intervention |
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Subjective Memory Loss in Older Persons |
Dietary Supplement: Cerefolin NAC Dietary Supplement: Cerefolin NAC placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Six-Month, Double-Blind, Placebo-Controlled, Single Site Study of Cerefolin NAC on Blood Homocysteine, Oxidative Stress, and Beta-Amyloid Biomarkers That May Potentiate Inflammation and Neuronal Damage in Older Individuals With Memory Complaints Who Have Not Been Clinically Diagnosed With Mild Cognitive Impairment, Vascular Dementia, or Alzheimer's Disease |
Estimated Enrollment: | 100 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
On Cerefolin NAC and open-label multivitamin supplement
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Dietary Supplement: Cerefolin NAC
Cerefolin NAC one tablet each day
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2: Placebo Comparator
On placebo and open label multivitamin supplement
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Dietary Supplement: Cerefolin NAC placebo
Placebo tablet once a day
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Study Phase: Exploratory
Indication: Memory Complaints
Study Design:
A single-center, double-blind, placebo-controlled study with 100 subjects with memory complaints followed for 6 months (4 visits)using Cerefolin® NAC or placebo once a day in addition to a standardized multivitamin.
Sample Size:
100 subjects as follows:
Primary Objective:
To determine if Cerefolin® NAC (compared to multivitamin) decreases the blood level of homocysteine, increases the blood level of glutathione (a marker for oxidative stress), and increases the ratio of Aβ42 to Aβ40 (a marker for beta-amyloid) that may be related to neuronal injury and inflammation.
Secondary Objectives:
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Memory complaints as defined by two questions:
Exclusion Criteria:
Contact: Raj C Shah, MD | 312-563-2902 | Raj_C_Shah@rush.edu |
Contact: Theresa M Jenkins | 312-942-8264 | Theresa_M_Jenkins@rush.edu |
United States, Illinois | |
Rush Alzheimer's Disease Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Theresa M Jenkins 312-942-8264 Theresa_M_Jenkins@rush.edu | |
Contact: Raj C Shah, MD 312-563-2902 Raj_C_Shah@rush.edu | |
Principal Investigator: Raj C Shah, MD |
Principal Investigator: | Raj C Shah, MD | Rush University Medical Center |
Responsible Party: | Rush University Medical Center ( Raj C. Shah, MD (Principal Investigator) ) |
Study ID Numbers: | Pamlab-Cerefolin NAC-001-01 |
Study First Received: | January 9, 2008 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00597376 |
Health Authority: | United States: Institutional Review Board |
memory loss |
Hydroxocobalamin Alzheimer Disease Vitamin B 12 Stress Memory Disorders Cognition Disorders Inflammation Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Acetylcysteine Dementia, Vascular Neurologic Manifestations Dementia Neurobehavioral Manifestations N-monoacetylcystine Amnesia Delirium |
Respiratory System Agents Anti-Infective Agents Vitamin B Complex Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Nervous System Diseases Physiological Effects of Drugs Antiviral Agents |
Protective Agents Pharmacologic Actions Pathologic Processes Vitamins Expectorants Therapeutic Uses Free Radical Scavengers Micronutrients |