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

Completed

• Conditions: Early Memory Loss; Mild Cognitive Impairment; Alzheimer's Disease; Vascular Dementia
• Interventions: Other: CerefolinNAC®

• Registration Number: NCT01370954
• Lead Sponsor: Pamlab, Inc.

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 Description

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-10
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• New CerefolinNAC® Start
• Only for patients who have been prescribed CerefolinNAC® to help metabolic management of early memory loss.

Exclusion Criteria

• If a participant indicates that he or she did not get a prescription for CerefolinNAC®, he/she will not be able to complete the survey(s).
• For follow-up surveys, if the participant indicates that he/she has not been taking CerefolinNAC®, he/she will not be able to complete the survey (s).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CerefolinNAC®	CerefolinNAC®	Subjects diagnosed with Early Memory Loss who have been prescribed CerefolinNAC® daily.

Primary Outcome Measures

Name	Time	Method
To determine if CerefolinNAC® affects a subject's quality of life as measured by the Quality of Life-Alzheimer's Disease Scale (QOL-AD)	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.

Secondary Outcome Measures

Name	Time	Method
To determine overall patient satisfaction with CerefolinNAC® using a 9-point satisfaction scale	Weeks 6 and 12

Trial Locations

Locations (1)

Falls Neurology and Memory Center; 🇺🇸 Hickory, North Carolina, United States