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

NCT01370954 | Completed

• 1 other identifier: NAC-003
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Memory Loss; Mild Cognitive Impairment; Alzheimer's Disease; Vascular Dementia

Keywords

CerefolinNAC; early memory loss; pre-alzheimer's disease; cognitive function; folic acid; folate; L-methylfolate; vitamin B12; methylcobalamin; N-acetylcysteine; NAC; oxidative stress; memory deficit; antioxidant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To determine overall patient satisfaction with CerefolinNAC® using a 9-point satisfaction scale

  Weeks 6 and 12

Study Arms (1)

CerefolinNAC®

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

Other: CerefolinNAC®

Interventions

CerefolinNAC® OTHER

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.

CerefolinNAC®

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Early Memory Loss Who Have Been Prescribed CerefolinNAC®

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pamlab, Inc.: lead
• InfoMedics, Inc.: collaborator

Study Sites (1)

Falls Neurology and Memory Center

Hickory, North Carolina, 28601, United States

Location

MeSH Terms

Conditions

Memory Disorders; Cognitive Dysfunction; Alzheimer Disease; Dementia, Vascular

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Donald E Schmechel, M.D.

  Falls Neurology and Memory Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: June 10, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

US (1)