Clinical Trial: NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Pamlab, Inc.

Current Primary Outcome: 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 ]

The QOL-AD is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life.


Original Primary Outcome: Same as current

Current Secondary Outcome: To determine overall patient satisfaction with CerefolinNAC® using a 9-point satisfaction scale [ Time Frame: Weeks 6 and 12 ]

Original Secondary Outcome: Same as current

Information By: Pamlab, Inc.

Dates:
Date Received: May 20, 2011
Date Started: May 2011
Date Completion:
Last Updated: May 7, 2013
Last Verified: May 2013