A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients

Mild Cognitive Impairment Clinical Trial

Official title:

Hyperhomocysteinemia in a Mild Cognitive Impairment and Dementia Population: the Effect of Treatment With Cerefolin NAC® in a Naturalistic Community-based Dementia Practice

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01594541
• Other study ID #: NAC-004
• Status: Active, not recruiting
• Phase: N/A
• First received: April 3, 2012
• Last updated: March 21, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: March 2014
• Source: Pamlab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: April 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 89 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cognition Disorders
• Hyperhomocysteinemia
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	Clionsky Neuro Systems, Inc.	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Pamlab, Inc.	Clionsky Neuro Systems Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Levels of Homocysteine Over Time	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.	Week 6, Week 12, and Quaterly Thereafter @ 6 Month Intervals	No
Secondary	To evaluate the safety and tolerability of Cerefolin NAC® based on adverse events, discontinuation due to intolerability and compliance.		Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals	No
Secondary	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.		Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals	No