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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: CerefolinNAC®


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CerefolinNAC®<br>Subjects diagnosed with Early Memory Loss who have been prescribed CerefolinNAC® daily. | Other: CerefolinNAC®<br>* 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.<br>|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| To determine overall patient satisfaction with CerefolinNAC® using a 9-point satisfaction scale |  | Weeks 6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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