NAC-003 P.L.U.S. Program (Progress Through Learning Under... | NCT01370954

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

NCT01370954

Sponsor

Pamlab, Inc.

Status

Completed

Last Update Posted

May 9, 2013Estimated

Enrollment

204Actual

Phase

Not provided

Conditions

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

Interventions

CerefolinNAC®

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

May 20, 2011

First Submission Date that Met QC Criteria

Jun 8, 2011

First Posted Date

Jun 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2013

Last Update Posted Date

May 9, 2013Estimated

Name	Class
InfoMedics, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

204Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CerefolinNAC®		Subjects diagnosed with Early Memory Loss who have been prescribed CerefolinNAC® daily.	Other: CerefolinNAC®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Early Memory Loss Who Have Been Prescribed CerefolinNAC®

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donald E Schmechel, M.D.	Falls Neurology and Memory Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Falls Neurology and Memory Center		Hickory	North Carolina	28601	United States

Condition Browse Module

MeSH Terms

ID	Term
D008569	Memory Disorders
D060825	Cognitive Dysfunction
D000544	Alzheimer Disease
D015140	Dementia, Vascular

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided