NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)
This study will be an observational study in which patients who have been prescribed CerefolinNAC® are invited to participate in surveys regarding their experiences with CerefolinNAC®. CerefolinNAC® is a medical food indicated for the distinct nutritional requirements of individuals under treatment for early memory loss with particular emphasis for those individuals diagnosed with or at risk for neurovascular oxidative stress and/or hyperhomocysteinemia; mild to moderate cognitive impairment with or without vitamin B12 deficiency, vascular dementia or Alzheimer's disease. The purpose of this study is to increase the understanding of the role of CerefolinNAC® in managing proper neuronal function in the brain, provide patients with personalized education and support, and contribute to the overall understanding of the needs and concerns of patients being treated for early memory loss.
Early Memory Loss
Mild Cognitive Impairment
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)|
- To determine if CerefolinNAC® affects a subject's quality of life as measured by the Quality of Life-Alzheimer's Disease Scale (QOL-AD) [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]The QOL-AD is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life.
- To determine overall patient satisfaction with CerefolinNAC® using a 9-point satisfaction scale [ Time Frame: Weeks 6 and 12 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Subjects diagnosed with Early Memory Loss who have been prescribed CerefolinNAC® daily.
CerefolinNAC® is an orally-administered medical food, and each caplet contains 2 mg Methylcobalamin, 600 mg N-acetylcysteine, and 6 mg of L-methylfolate Calcium (as Metafolin®), which is the primary biologically active and immediately bioavailable form of folate. Dosage will be 1 caplet QD.
Surveys used to conduct this study will be administered via telephone by InfoMedics, Inc., a company with an established system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after CerefolinNAC® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. Patients self-enroll, take a brief survey before starting their CerefolinNAC® prescription, and then two brief follow-up surveys at 6 weeks and 12 weeks. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking CerefolinNAC® as directed. Patients will also receive educational materials about managing their early memory loss.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370954
|United States, North Carolina|
|Falls Neurology and Memory Center|
|Hickory, North Carolina, United States, 28601|
|Principal Investigator:||Donald E Schmechel, M.D.||Falls Neurology and Memory Center|