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

Launched by RUSH UNIVERSITY MEDICAL CENTER · Jan 9, 2008

Keywords

ClinConnect 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 str...

Gender

ALL

Eligibility 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.

Trial Officials