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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Dam

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.

Detailed 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
    Sponsor: Rush University Medical Center

    Current Primary Outcome: 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.


    Original Primary Outcome: 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 ]

    Current Secondary Outcome:

    • 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.
    • 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.


    Original Secondary Outcome:

    • Assess the tolerability of Cerefolin NAC [ Time Frame: 6 months ]
    • Assess if Cerefolin NAC reduces secondary measures of inflammation and oxidative stress [ Time Frame: 6 months ]
    • Explore the effects of Cerefolin NAC on cognitive test performance, activities of daily living, mood, and physical function [ Time Frame: 6 months ]
    • Explore how change in homocysteine levels is associated with change in inflammatory, oxidative stress, and beta-amyloid markers. [ Time Frame: 6 months ]
    • Explore the interaction of genetic markers on the relationship between change in homocysteine levels and change in the measured biomarkers [ Time Frame: 6 months ]
    • Explore relationship of vitamin B12 levels to cognitive function [ Time Frame: 6 months ]


    Information By: Rush University Medical Center

    Dates:
    Date Received: January 9, 2008
    Date Started: November 2007
    Date Completion:
    Last Updated: May 20, 2013
    Last Verified: May 2013