A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients

March 21, 2014 updated by: Pamlab, Inc.

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.

Study Overview

Status

Unknown

Conditions

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Springfield, Massachusetts, United States, 01105
        • Clionsky Neuro Systems, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients Treated with CerefolinNAC®
Patients Not Treated with CerefolinNAC®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Levels of Homocysteine Over Time
Time Frame: Week 6, Week 12, and Quaterly Thereafter @ 6 Month Intervals
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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals
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
Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamlab, Inc.

Collaborators

Clionsky Neuro Systems Inc.

Investigators

  • Principal Investigator: Emily Clionsky, MD, Clionsky Neuro Systems Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

May 8, 2012

First Posted (Estimate)

May 9, 2012

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAC-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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