NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)
|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.|
|ClinicalTrials.gov Identifier: NCT01370954|
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : May 9, 2013
|Condition or disease||Intervention/treatment|
|Early Memory Loss Mild Cognitive Impairment Alzheimer's Disease Vascular Dementia||Other: CerefolinNAC®|
|Study Type :||Observational|
|Actual Enrollment :||204 participants|
|Official Title:||NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
Subjects diagnosed with Early Memory Loss who have been prescribed CerefolinNAC® daily.
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.
- 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.
- To determine overall patient satisfaction with CerefolinNAC® using a 9-point satisfaction scale [ Time Frame: Weeks 6 and 12 ]
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
|United States, North Carolina|
|Falls Neurology and Memory Center|
|Hickory, North Carolina, United States, 28601|
|Principal Investigator:||Donald E Schmechel, M.D.||Falls Neurology and Memory Center|