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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Vascular Dementia; Alzheimer's Disease; Early Memory Loss
• Intervention / Treatment: Other: CerefolinNAC®

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 Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Falls Neurology and Memory Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Early Memory Loss Who Have Been Prescribed CerefolinNAC®

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CerefolinNAC®; Subjects diagnosed with Early Memory Loss who have been prescribed CerefolinNAC® daily.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine overall patient satisfaction with CerefolinNAC® using a 9-point satisfaction scale	Weeks 6 and 12

Collaborators and Investigators

• Sponsor: Pamlab, Inc.
• Collaborators: InfoMedics, Inc.
• Investigators: Principal Investigator: Donald E Schmechel, M.D., Falls Neurology and Memory Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 10, 2011

Study Record Updates

• Last Update Posted (Estimate): May 9, 2013
• Last Update Submitted That Met QC Criteria: May 7, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: cognitive function; oxidative stress; N-acetylcysteine; antioxidant; NAC; vitamin B12; folate; L-methylfolate; folic acid; methylcobalamin; memory deficit; CerefolinNAC; early memory loss; pre-alzheimer's disease
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Alzheimer Disease; Cognitive Dysfunction; Dementia, Vascular; Memory Disorders; Amnesia
• Other Study ID Numbers: NAC-003