Expired Study
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Chicago, Illinois 60612


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.


Study summary:

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: 1. 50 on Cerefolin® NAC + multivitamin; and, 2. 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: 1. To determine if Cerefolin® NAC reduces hs-CRP and TNF-α blood levels, and increases IL-6 blood levels. 2. To determine if Cerefolin® NAC (compared to Placebo) reduces plasma F2 isoprostane and increases potential antioxidant (PAO) levels. 3. To assess the tolerability of Cerefolin® NAC 4. 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. 5. 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. 6. To explore the effects of MS AG2756, APOE and MFTHR on the relationship examined in Secondary Objective #5. 7. 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.


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.


Study is Available At:


Original ID:

Pamlab-Cerefolin NAC-001-


NCT ID:

NCT00597376


Secondary ID:


Study Acronym:


Brief Title:

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


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 Hav


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Rush University Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

104


Enrollment Type:

Actual


Overall Contact Information

Official Name:Raj C Shah, MD
Principal Investigator
Rush University Medical Center

Study Dates

Start Date:November 2007
Completion Date:May 2011
Completion Type:Actual
Primary Completion Date:May 2011
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 20, 2013
First Received Date:January 9, 2008
First Results Date:January 25, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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. En
Outcome Type:Secondary Outcome
Measure:Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only
Time Frame:6 months
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Other
Name:Cerefolin NAC (a medical food)
Description:Cerefolin NAC one tablet each day
Arm Name:1
Intervention Type:Other
Name:Cerefolin NAC placebo
Description:Placebo tablet once a day
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:On Cerefolin NAC and open-label multivitamin supplement
Study Arm Type:Placebo Comparator
Arm Name:2
Description:On placebo and open label multivitamin supplement

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Rush University Medical Center
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Pamlab, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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