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

Completed · Not applicable · Has a placebo group

Conditions studied: Subjective Memory Loss in Older Persons

In brief

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.

Key facts

Study ID

NCT00597376

Run by

Rush University Medical Center

People needed

104

Starts

2007-11-01

Expected to finish

2011-05-01

Last updated by the study team

2013-05-23

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rush Alzheimer's Disease Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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