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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370954
First Posted: June 10, 2011
Last Update Posted: May 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
InfoMedics, Inc.
Information provided by (Responsible Party):
Pamlab, Inc.
  Purpose
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.

Condition Intervention
Early Memory Loss Mild Cognitive Impairment Alzheimer's Disease Vascular Dementia Other: CerefolinNAC®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)

Resource links provided by NLM:


Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • 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.


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

Enrollment: 204
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Early Memory Loss Who Have Been Prescribed CerefolinNAC®
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370954


Locations
United States, North Carolina
Falls Neurology and Memory Center
Hickory, North Carolina, United States, 28601
Sponsors and Collaborators
Pamlab, Inc.
InfoMedics, Inc.
Investigators
Principal Investigator: Donald E Schmechel, M.D. Falls Neurology and Memory Center
  More Information

Responsible Party: Pamlab, Inc.
ClinicalTrials.gov Identifier: NCT01370954     History of Changes
Other Study ID Numbers: NAC-003
First Submitted: May 20, 2011
First Posted: June 10, 2011
Last Update Posted: May 9, 2013
Last Verified: May 2013

Keywords provided by Pamlab, Inc.:
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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Cognitive Dysfunction
Dementia, Vascular
Memory Disorders
Amnesia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Acetylcysteine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents