Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Pamlab, Inc.
Information provided by (Responsible Party):
Raj C Shah, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00597376
First received: January 9, 2008
Last updated: May 20, 2013
Last verified: May 2013
Results First Received: January 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Subjective Memory Loss in Older Persons
Interventions: Other: Cerefolin NAC (a medical food)
Other: Cerefolin NAC placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between March 2008 and September 2009, persons expressing study interest at community presentations or at the Rush Memory Clinic were contacted. Of 524 persons expressing interest, 400 were excluded before consenting for having excluding clinical diagnoses(227), participation refusal (119), and other exclusions medication (54).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Consented participants underwent a screening evaluation to ensure inclusion criteria were met prior to study treatment assignment and one month run-in treatment with a multivitamin only. Of 124 consented individuals, 20 discontinued prior to randomization due to new medical conditions (9), declining participation (5), and for other reasons (6).

Reporting Groups
  Description
Cerefolin NAC + Multivitamin

On Cerefolin NAC and open-label multivitamin supplement

Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day

Cerefolin NAC Placebo + Multivitamin

On placebo and open label multivitamin supplement

Cerefolin NAC placebo : Placebo tablet once a day


Participant Flow:   Overall Study
    Cerefolin NAC + Multivitamin     Cerefolin NAC Placebo + Multivitamin  
STARTED     51     53  
COMPLETED     43 [1]   49 [2]
NOT COMPLETED     8     4  
Withdrawal by Subject                 4                 3  
Adverse Event                 4                 1  
[1] All participants started (51) were included in primary analyses.
[2] All participants started (53) were included in primary analyses.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cerefolin NAC + Multivitamin

On Cerefolin NAC and open-label multivitamin supplement

Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day

Cerefolin NAC Placebo + Multivitamin

On placebo and open label multivitamin supplement

Cerefolin NAC placebo : Placebo tablet once a day

Total Total of all reporting groups

Baseline Measures
    Cerefolin NAC + Multivitamin     Cerefolin NAC Placebo + Multivitamin     Total  
Number of Participants  
[units: participants]
  51     53     104  
Age  
[units: years]
Mean ± Standard Deviation
  80.9  ± 6.6     79.4  ± 8.7     80.1  ± 7.7  
Gender  
[units: participants]
     
Female     46     42     88  
Male     5     11     16  
Region of Enrollment  
[units: participants]
     
United States     51     53     104  
Education Level  
[units: years]
Mean ± Standard Deviation
  15  ± 3     15  ± 3     15  ± 3  
total plasma homocysteine  
[units: micromol/L]
Geometric Mean ± Standard Deviation
  8.35  ± 1.32     8.10  ± 1.33     8.22  ± 1.33  
glutathione  
[units: micromol/L]
Geometric Mean ± Standard Deviation
  4.01  ± 1.67     4.02  ± 1.59     4.02  ± 1.63  
ratio of amyloid beta 1-42 to 1-40  
[units: pmol/L:pmol/L]
Geometric Mean ± Standard Deviation
  0.027  ± 1.73     0.034  ± 1.81     0.031  ± 1.77  
highly sensitive c-Reactive Protein  
[units: mg/mL]
Geometric Mean ± Standard Deviation
  0.20  ± 18.93     0.23  ± 22.37     0.22  ± 20.68  
tumor necrosis factor alpha  
[units: pg/mL]
Geometric Mean ± Standard Deviation
  1.45  ± 1.61     1.37  ± 1.53     1.41  ± 1.57  
interleukin-6  
[units: pg/mL]
Geometric Mean ± Standard Deviation
  2.12  ± 1.98     2.12  ± 2.35     2.12  ± 2.17  
malondialdehyde  
[units: micromol/L]
Geometric Mean ± Standard Deviation
  0.90  ± 1.67     0.93  ± 1.75     0.92  ± 1.71  
potential anti-oxidant (PAO) [1]
[units: micromol/L]
Geometric Mean ± Standard Deviation
  979  ± 2     1016  ± 2     997  ± 2  
[1] Potential anti-oxidant (PAO) measures the antioxidant capacity of a serum sample to reduce cupric ions from Cu++ to Cu+.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only   [ Time Frame: 6 months ]

3.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No limitations or caveats to report.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Raj C. Shah, MD
Organization: Rush University Medical Center
phone: 312-563-2902
e-mail: Raj_C_Shah@rush.edu


No publications provided


Responsible Party: Raj C Shah, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00597376     History of Changes
Other Study ID Numbers: Pamlab-Cerefolin NAC-001-01
Study First Received: January 9, 2008
Results First Received: January 25, 2013
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board