Clinical trial: Study of the Effects of Cerefolin NAC on Inflammation Blood Markers in Older Individuals With Memory Complaints (NCT00597376)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.


Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Contradiction