Clinical trial NCT01370954: NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)
Official title: NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Pamlab, Inc.
Sponsor class: INDUSTRY
Collaborators: name: InfoMedics, Inc.
First posted: 2011-06-10
Enrollment: 204
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Early Memory Loss Who Have Been Prescribed CerefolinNAC®

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.

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).

Primary outcomes:
measure: To determine if CerefolinNAC® affects a subject's quality of life as measured by the Quality of Life-Alzheimer's Disease Scale (QOL-AD)
timeFrame: Baseline, Week 6 and Week 12
Secondary outcomes:
measure: To determine overall patient satisfaction with CerefolinNAC® using a 9-point satisfaction scale
timeFrame: Weeks 6 and 12
Other outcomes:
Locations:
city: Hickory
country: United States
facility: Falls Neurology and Memory Center
state: North Carolina
Study officials:
affiliation: Falls Neurology and Memory Center
name: Donald E Schmechel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: