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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370954
• Other study ID #: NAC-003
• Status: Completed
• Phase: N/A
• First received: May 20, 2011
• Last updated: May 7, 2013
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Pamlab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Amnesia
• Cognition Disorders
• Dementia, Vascular
• Early Memory Loss
• Mild Cognitive Impairment
• Vascular Dementia

Intervention

Other:
• CerefolinNAC®
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.

Locations

Country	Name	City	State
United States	Falls Neurology and Memory Center	Hickory	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Pamlab, Inc.	InfoMedics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if CerefolinNAC® affects a subject's quality of life as measured by the Quality of Life-Alzheimer's Disease Scale (QOL-AD)	The QOL-AD is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life.	Baseline, Week 6 and Week 12	No
Secondary	To determine overall patient satisfaction with CerefolinNAC® using a 9-point satisfaction scale		Weeks 6 and 12	No