A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Clionsky Neuro Systems Inc.
Information provided by (Responsible Party):
Pamlab, Inc.
ClinicalTrials.gov Identifier:
NCT01594541
First received: April 3, 2012
Last updated: March 21, 2014
Last verified: March 2014

April 3, 2012
March 21, 2014
January 2013
August 2013   (final data collection date for primary outcome measure)
Change from Baseline in Levels of Homocysteine Over Time [ Time Frame: Week 6, Week 12, and Quaterly Thereafter @ 6 Month Intervals ] [ Designated as safety issue: No ]
To analyze homocysteine levels, cognitive test scores and depression level to determine the prevalence of hyperhomocysteinemia and associated metabolic abnormalities and compare results of patients on Cerefolin NAC® alone to patients on Cerefolin NAC® in combination with standard of care memory and/or depression medications.
Same as current
Complete list of historical versions of study NCT01594541 on ClinicalTrials.gov Archive Site
  • To evaluate the safety and tolerability of Cerefolin NAC® based on adverse events, discontinuation due to intolerability and compliance. [ Time Frame: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals ] [ Designated as safety issue: No ]
  • Examine the demographics, medical co-morbidities present and affective and cognitive characteristics of the group of patients demonstrating hyperhomocysteinemia compared with the group without hyperhomocysteinemia in a dementia population. [ Time Frame: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of Cerefolin NAC® based on adverse events, discontinuation due to intolerability and compliance. [ Time Frame: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals ] [ Designated as safety issue: No ]
  • Examine the demographics, medical co-morbidities present and effective and cognitive characteristics of the group of patients demonstrating hyperhomocysteinemia compared with the group without hyperhomocysteinemia in a dementia population. [ Time Frame: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients
Hyperhomocysteinemia in a Mild Cognitive Impairment and Dementia Population: the Effect of Treatment With Cerefolin NAC® in a Naturalistic Community-based Dementia Practice

This retrospective analysis of de-identified data from 700 charts of consecutive patients from this patient population is to investigate the prevalence of hyperhomocysteinemia and associated metabolic abnormalities in this naturalistic grouping of patients with various stages of cognitive loss and diagnosed with various types of dementia.

A single-center, retrospective review of the medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss including analysis of:

Laboratory values of interest: homocysteine, methylmalonic acid, CRP, BNP, CO2, TSH, Fe/TIBC, RPR/TPPA/FTA-ABS, and if available, folic acid and B12 levels ordered by primary care providers.

Neuropsychological tests of executive function, memory and affect:

  • Wechsler Memory Scale-Revised (WMS-R) or Fourth Edition (WMS-IV)

    • Logical Memory -Delayed Recall, Scaled Score
    • Visual Reproduction-Delayed Recall, Scaled Score
  • Shopping List Test, Delayed Recall
  • Trailmaking A and B Tests
  • Verbal Absurdities subtest of the Stanford Binet, Form L-M
  • Proverbs Test
  • Memory Orientation Screening Test
  • Folstein Mini-Mental State Exam
  • Geriatric Depression Scale, 15 items

Sub-group analysis of MRI volumetrics and PET scans when available. Sequentially pulled from June 1, 2009 to September 2011

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss.

Mild Cognitive Impairment
Not Provided
  • Patients Treated with CerefolinNAC®
  • Patients Not Treated with CerefolinNAC®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
700
April 2014
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals between the ages of 55 and 89 years old
  • Meeting criteria for Mild Cognitive Impairment or dementia with a minimum MOST score of 5 but not over 23
  • Has a minimum of 3 months evaluation
  • Able to undergo testing for cognition and complete the GDS

Exclusion Criteria:

  • Known allergy/intolerance to any ingredient in Cerefolin NAC®
  • Substantial impediments to adherence, such as severe dementia without caregiver to administer medication
  • Inability to swallow pill-form medication
  • Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
  • Hcy score lower than 11
Both
55 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01594541
NAC-004
No
Pamlab, Inc.
Pamlab, Inc.
Clionsky Neuro Systems Inc.
Principal Investigator: Emily Clionsky, MD Clionsky Neuro Systems Inc.
Pamlab, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP