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
Study Phase: Exploratory
Indication: Memory Complaints
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.
100 subjects as follows:
1. 50 on Cerefolin® NAC + multivitamin; and,
2. 50 on Placebo + multivitamin.
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.
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 as measured by SF-36, (c)instrumental and basic activities of daily living,
(d)MADRS; and (e)performance-based physical function.
5. To explore if a change in homocysteine level is related to a change in the plasma
glutathione, hs-CRP, IL-6, TNF-α, F2-isoprostane, and PAO levels and to a change in the
ratio of Aβ42 to Aβ40.
6. To explore the effects of MS AG2756, APOE and MFTHR on the relationship examined in
Secondary Objective #5.
7. To explore the relationship of B12 status and status to cognition
NOTE: For individuals successfully completing the 6-month blinded phase, there is an
12-month open-label extension of Cerefolin NAC + multivitamin. The primary purpose of the
exploratory, open-label extension phase of the CERE-001 study is to systematically collect
long-term safety data on CEREFOLIN NAC usage over an additional 12-month period.
- 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.
- 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.