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

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ClinicalTrials.gov Identifier: NCT00597376
Recruitment Status : Completed
First Posted : January 18, 2008
Results First Posted : May 23, 2013
Last Update Posted : May 23, 2013
Pamlab, Inc.
Information provided by (Responsible Party):
Raj C Shah, Rush University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Subjective Memory Loss in Older Persons Other: Cerefolin NAC (a medical food) Other: Cerefolin NAC placebo Not Applicable

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : November 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: 1
On Cerefolin NAC and open-label multivitamin supplement
Other: Cerefolin NAC (a medical food)
Cerefolin NAC one tablet each day

Placebo Comparator: 2
On placebo and open label multivitamin supplement
Other: Cerefolin NAC placebo
Placebo tablet once a day

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597376

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United States, Illinois
Rush Alzheimer's Disease Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Pamlab, Inc.
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Principal Investigator: Raj C Shah, MD Rush University Medical Center
Additional Information:
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Responsible Party: Raj C Shah, Assistant Professor, Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00597376    
Other Study ID Numbers: Pamlab-Cerefolin NAC-001-01
First Posted: January 18, 2008    Key Record Dates
Results First Posted: May 23, 2013
Last Update Posted: May 23, 2013
Last Verified: May 2013
Keywords provided by Raj C Shah, Rush University Medical Center:
memory loss
Additional relevant MeSH terms:
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Memory Disorders
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders