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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 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
Mild Cognitive Impairment

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 700
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients Treated with CerefolinNAC®
Patients Not Treated with CerefolinNAC®

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

  Eligibility

Ages Eligible for Study:   55 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594541

Locations
United States, Massachusetts
Clionsky Neuro Systems, Inc.
Springfield, Massachusetts, United States, 01105
Sponsors and Collaborators
Pamlab, Inc.
Clionsky Neuro Systems Inc.
Investigators
Principal Investigator: Emily Clionsky, MD Clionsky Neuro Systems Inc.
  More Information

No publications provided

Responsible Party: Pamlab, Inc.
ClinicalTrials.gov Identifier: NCT01594541     History of Changes
Other Study ID Numbers: NAC-004
Study First Received: April 3, 2012
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pamlab, Inc.:
hyperhomocysteinemia
dementia
depression
 vitamin B12
mild cognitive impairment
alzheimer's

Additional relevant MeSH terms:
Cognition Disorders
Hyperhomocysteinemia
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
 Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 19, 2013