N/A
Completed N=104
Study of the Effects of Cerefolin NAC on Inflammation Blood Markers in Older Individuals With Memory Complaints
Subjective Memory Loss in Older Persons
Source: ClinicalTrials.gov NCT00597376 ↗
Enrolled (actual)
104
Serious AEs
18.3%
Results posted
May 2013
Primary outcomePrimary: 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 — 71; 101; 115; 101 percent of baseline level
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
71; 101; 115; 101; 101; 104 | — |
| SECONDARY Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only |
88; 88 | — |
| 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 |
110; 111; 99; 108; 114; 105 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
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.
Data sourced from ClinicalTrials.gov (NCT00597376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.