- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00597376
Study of the Effects of Cerefolin NAC on Inflammation Blood Markers in Older Individuals With Memory Complaints
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
Study Overview
Status
Conditions
Intervention / Treatment
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
NOTE: For individuals successfully completing the 6-month blinded phase, there is an 12-month open-label extension of Cerefolin NAC + multivitamin. The primary purpose of the exploratory, open-label extension phase of the CERE-001 study is to systematically collect long-term safety data on CEREFOLIN NAC usage over an additional 12-month period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush Alzheimer's Disease Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age greater than 60;
Memory complaints as defined by two questions:
- "Do The subject think your have memory problems?"; and,
- "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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
On Cerefolin NAC and open-label multivitamin supplement
|
Cerefolin NAC one tablet each day
|
Placebo Comparator: 2
On placebo and open label multivitamin supplement
|
Placebo tablet once a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six Month Blood Levels of Homocysteine, Glutathione, and the Ratio of Aβ42 to Aβ40 (as a Percent of Baseline Levels) After Daily Intake of Cerefolin NAC Plus a Multivitamin Versus a Multivitamin Only
Time Frame: 6 months
|
Primary outcome markers were plasma homocysteine (tHcy), glutathione, and the ratio of amyloid proteins, Aβ42 and Aβ40.
Plasma tHcy and glutathione were assayed using a high performance liquid chromatography (HPLC) with fluorescence detection method.
Enzyme-linked immunosorbent assays (ELISA) were used for Aβ42 (Wako Chemicals USA, Inc., Richmond, VA) and Aβ40 (Invitrogen Corporation, Canarillo, CA) detection.
Primary analyses utilized Last Observation Carried Forward (LOCF) to assess the primary biomarker level at 6 months versus baseline.
Six month levels in biomarker outcomes were compared using t-tests of the logarithmically transformed values and the antilogarithm was applied to the SDs obtain 95% confidence intervals (95% CIs).
A significant difference between treatments was needed for at least one of the primary outcome variables (tHcy, glutathione, or the Aβ42 to Aβ40 ratio) to declare the study positive.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only
Time Frame: 6 months
|
Mean study product compliance was measured as the actual number of study product tablets taken as a percent of the maximum study product tablets that could have been taken during the intervention period.
|
6 months
|
Six Month Levels of Inflammation and Oxidative Stress Markers(as a Percent of Baseline Levels) After Daily Treatment With Cerefolin NAC and a Multivitamin or a Multivitamin Only
Time Frame: 6 months
|
Outcome measures were 6-month levels of highly sensitive c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6), malondialdehyde, and potential anti-oxidant (PAO)in blood samples as a percent of baseline value.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Raj C Shah, MD, Rush University Medical Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pamlab-Cerefolin NAC-001-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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