ClinicalTrials.gg
CompletedNCT01370954Updated May 9, 2013

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

An observational study in Early Memory Loss, Mild Cognitive Impairment and Alzheimer's Disease, sponsored by Pamlab, Inc.. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-09.

Sponsored by Pamlab, Inc. (part of Alfasigma S.p.A.) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
204
Ages
50 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 224 studies in Memory Disorders with a site in United States — 34 open to participants now, 51 under way, none of them phase 3. Memory Disorders · United States.

Enrollment
15th of 33
204 · median 197
Started
2011
with 6 others
Observational
33 of 224
5 open now
Registered
63rd of 224
by date

Among the 224 studies in Memory Disorders with a site in United States, this one is the 15th largest by enrollment of the 33 observational ones that give a count, is one of 7 that started in 2011, is one of 33 observational ones, and was the 63rd registered.

Memory Disorders

373 studies on the registry are indexed under Memory Disorders; 67 are open to participants now.

Browse Memory Disorders studies →

Open to participants now

34 of the 224 studies in Memory Disorders with a site in United States are open now. Recruiting first, the newest first:

29 more — sign in →

All 34 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 54 Memory Disorders studies recruiting now, 27 (50%) set no upper age limit and 13 (24%) stop at 75 or younger; 3 take children under 18; 22 take healthy volunteers.

This study: 50 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 224 studies in Memory Disorders with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with Early Memory Loss Who Have Been Prescribed CerefolinNAC®

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
204 participants (actual)

Groups and cohorts

  • CerefolinNAC®

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

    Other: CerefolinNAC®

Interventions

  • OtherCerefolinNAC®

    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.

06

What researchers measure

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.

    Time frame: Baseline, Week 6 and Week 12

Secondary outcomes

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

    Time frame: Weeks 6 and 12

07

Study locations

1 site
  • Falls Neurology and Memory Center
    Hickory, North Carolina 28601, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Nov 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2011
First posted
Jun 10, 2011
Start
May 2011
Primary completionActual
Nov 2012
CompletionActual
Dec 2012
Last update
May 9, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01370954
Lead sponsor
Pamlab, Inc.
Collaborators
InfoMedics, Inc.
Responsible party
Sponsor
First posted
Jun 10, 2011
Start date
May 2011
Primary completion
Nov 2012
Completion
Dec 2012
Last update
May 9, 2013

Study contacts

Donald E Schmechel, M.D.
principal investigator · Falls Neurology and Memory Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion