A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients

Pamlab

Status: Unknown

Conditions: Mild Cognitive Impairment

Study type: Observational

Funder types: Industry

Identifiers

NCT01594541

NAC-004

Details and patient eligibility

About

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.

Full description

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

Enrollment: 700 estimated patients

Sex: All

Ages: 55 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

700 participants in 2 patient groups

Patients Treated with CerefolinNAC®

Patients Not Treated with CerefolinNAC®