On 2017 Jan 13, Craig Brown commented:

I would welcome more research in this matter, also. As a clinician, for many years I have found this to yield significant visual and cognitive functional improvement in many patients with mild to moderate cerebral atrophy and vascular dementia, particularly those with MTHFR polymorphisms.

Over several years, the benefit has been reliable. Patients who quit it, often come back and and restart it, because they notice loss of functional improvements that returns upon resumption.

Because Folic acid does not cross the Blood Brain Barrier, it can build up blocking active l-methylfolate transport into the brain and retina, also impairing DHFR, Dihydrofolate Reductase which impairs methylation and BH4 recycling- essential for serotonin, dopamine, and norepinephrine production- which in turn are essential for mood, attention,sleep and memory.

I find it works optimally when combined with Folic Acid avoidance- to reduce BBB blockade, riboflavin to enhance MTHFR methylation, and Vitamin D to enhance folate absorption. It has a long record of safety, with few serious side effects, for a condition that has few effective treatments. All this is to say, more research is surely a good thing here, but excessive skepticism deprives patients of a chance to try a low risk frequently helpful but not magic option.

It is classified as a Medical Food, in part, because our FDA does not encourage formulating drug products that have multiple active ingredients, particularly ingredients that occur naturally in foods and in human metabolism. Medical Foods were implemented by the FDA specifically for higher concentrations of natural food based substances important to address genetic metabolic impairments, in this case, impairment of DFHR and MTHFR; which may contribute to cerebral ischemia, atrophy, and dementia.

A final thought, double blind experiments are the ideal gold standard, however, the elderly, and the demented are considered high risk populations and have such strong protections in place at the NIH, that placebo studies are difficult to justify to, or get approval from, any Institutional Review Board IRB, when previous benefit has been shown, because that amounts to knowingly withholding treatment. We may have to content ourselves with non-placebo trials.

On 2016 Nov 09, Gayle Scott commented:

This company (Nestle Health Science - Pamlab, Inc)-sponsored study was neither randomized nor blinded. Tests of cognitive function and QOL were not included.The study will certainly be cited in advertising for CerefolinNAC.

It is important to note CerefolinNAC is a "medical food," an FDA designation for products designed to meet the nutritional needs of patients whose needs cannot be met through foods, such as inborn errors of metabolism, eg PKU (patients must avoid phenylalanine), maple syrup urine disease (patients must avoid branched chain amino acids).

Another medical food for Alzheimer's disease is Axona, caprylic triglyceride, a medium chain triglyceride found in coconut oil. Unlike dietary supplements, medical foods can be labeled for medical conditions such as Alzheimer’s disease. Dietary supplements must be labeled for so-called “structure and function claims” and cannot make claims to treat or prevent disease. For example, ginkgo may be labeled “supports memory function,” but not “for treatment of dementia.” A drug or medical food could be labeled “for treatment of dementia associated with Alzheimer’s disease.”

Think of medical foods as hybrids of prescription drugs and dietary supplements, more closely resembling dietary supplements in terms of regulation. Packaging for medical foods is similar to prescription products with package inserts, NDC numbers, and usually “Rx only” on the labels. But like dietary supplements, medical foods are not required to be evaluated for safety or efficacy, and the FDA does not require approval before marketing. "Caution: Federal law prohibits dispensing without prescription" is not required on product labeling. The FDA specifies only that these products are for use with medical supervision;. however, a medical food manufacturer may market a product to be dispensed only on physician request.

Message to patients regarding CerefolinNAC: much more research is needed.

On 2016 Nov 09, Gayle Scott commented:

This company (Nestle Health Science - Pamlab, Inc)-sponsored study was neither randomized nor blinded. Tests of cognitive function and QOL were not included.The study will certainly be cited in advertising for CerefolinNAC.

It is important to note CerefolinNAC is a "medical food," an FDA designation for products designed to meet the nutritional needs of patients whose needs cannot be met through foods, such as inborn errors of metabolism, eg PKU (patients must avoid phenylalanine), maple syrup urine disease (patients must avoid branched chain amino acids).

Another medical food for Alzheimer's disease is Axona, caprylic triglyceride, a medium chain triglyceride found in coconut oil. Unlike dietary supplements, medical foods can be labeled for medical conditions such as Alzheimer’s disease. Dietary supplements must be labeled for so-called “structure and function claims” and cannot make claims to treat or prevent disease. For example, ginkgo may be labeled “supports memory function,” but not “for treatment of dementia.” A drug or medical food could be labeled “for treatment of dementia associated with Alzheimer’s disease.”

Think of medical foods as hybrids of prescription drugs and dietary supplements, more closely resembling dietary supplements in terms of regulation. Packaging for medical foods is similar to prescription products with package inserts, NDC numbers, and usually “Rx only” on the labels. But like dietary supplements, medical foods are not required to be evaluated for safety or efficacy, and the FDA does not require approval before marketing. "Caution: Federal law prohibits dispensing without prescription" is not required on product labeling. The FDA specifies only that these products are for use with medical supervision;. however, a medical food manufacturer may market a product to be dispensed only on physician request.

Message to patients regarding CerefolinNAC: much more research is needed.