Study of the Effects of Cerefolin NAC on Inflammation Blood Markers in Older Individuals With Memory Complaints - Full Text View

Sponsors and Collaborators:	Rush University Medical Center Pamlab, L.L.C.
Information provided by:	Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT00597376

Purpose

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
Subjective Memory Loss in Older Persons	Dietary Supplement: Cerefolin NAC Dietary Supplement: Cerefolin NAC placebo

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Dietary Supplements Memory

Drug Information available for: Homocysteine

U.S. FDA Resources

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

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:

To determine if Cerefolin® NAC (compared to multivitamin) decreases the blood level of homocysteine, increases the blood level of glutathione, and increases the ratio of Aβ42 to Aβ40 that may be related to neuronal injury and inflammation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the tolerability of Cerefolin NAC [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Assess if Cerefolin NAC reduces secondary measures of inflammation and oxidative stress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Explore the effects of Cerefolin NAC on cognitive test performance, activities of daily living, mood, and physical function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Explore how change in homocysteine levels is associated with change in inflammatory, oxidative stress, and beta-amyloid markers. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Explore the interaction of genetic markers on the relationship between change in homocysteine levels and change in the measured biomarkers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Explore relationship of vitamin B12 levels to cognitive function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
1: Experimental On Cerefolin NAC and open-label multivitamin supplement	Dietary Supplement: Cerefolin NAC Cerefolin NAC one tablet each day
2: Placebo Comparator On placebo and open label multivitamin supplement	Dietary Supplement: Cerefolin NAC placebo Placebo tablet once a day

Detailed Description:

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:

50 on Cerefolin® NAC + multivitamin; and,
50 on Placebo + multivitamin.

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:

To determine if Cerefolin® NAC reduces hs-CRP and TNF-α blood levels, and increases IL-6 blood levels.
To determine if Cerefolin® NAC (compared to Placebo) reduces plasma F2 isoprostane and increases potential antioxidant (PAO) levels.
To assess the tolerability of Cerefolin® NAC
To explore the effects of Cerefolin® NAC on a 6-month change in: (a)global and specific cognitive domains in a standardized neuropsychological test battery,(b) quality of life as measured by SF-36, (c)instrumental and basic activities of daily living, (d)MADRS; and (e)performance-based physical function.
To explore if a change in homocysteine level is related to a change in the plasma glutathione, hs-CRP, IL-6, TNF-α, F2-isoprostane, and PAO levels and to a change in the ratio of Aβ42 to Aβ40.
To explore the effects of MS AG2756, APOE and MFTHR on the relationship examined in Secondary Objective #5.
To explore the relationship of B12 status and status to cognition

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater than 60;
Memory complaints as defined by two questions:
1. "Do The subject think your have memory problems?"; and,
2. "Has there been a decline in your memory over the last 10 years?"
Fluency in English;
Ability to ingest oral medications; and,
Willing to replace current vitamin intake with a standardized multivitamin provided for the study.

Exclusion Criteria:

Clinical stroke or Parkinson's disease;
Taking FDA approved drug for symptomatic treatment of Alzheimer's disease (Aricept, Razadyne, Exelon, and/or Namenda);
History of significant renal insufficiency (creatinine ≥1.5);
History of renal stones or peptic ulcer disease;
Use of vitamin supplements containing more than 400mcg of folic acid per day within 2 months of Screen Visit;
As determined by the study physician, clinically significant serum folate and vitamin B12 deficiency on screening blood tests that would require further clinical evaluation and treatment
As determined by the study physician, clinically significant medical conditions, physical exam findings or abnormal blood tests at screening that would require further clinical evaluation and treatment
B12 injections 6 months prior to the Screen Visit;
Confirmed clinical diagnosis of Mild Cognitive Impairment (MCI), vascular dementia or Alzheimer's Disease (AD); and,
Known hypersensitivity to L-methylfolate, methyl-cobalamin or N-acetylcysteine.
Use of any other investigational agent used during the 30 days prior to Screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597376

Contacts

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

Locations

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

Sponsors and Collaborators

Rush University Medical Center

Pamlab, L.L.C.

Investigators

Principal Investigator:

Raj C Shah, MD

Rush University Medical Center

More Information

Rush Alzheimer's Disease Center This link exits the ClinicalTrials.gov site

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

Keywords provided by Rush University Medical Center:

memory loss

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009