A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients

• ClinicalTrials.gov Identifier: NCT01594541
• Recruitment Status: Unknown
• First Posted: May 9, 2012
• Last Update Posted: March 24, 2014
• Sponsor: Pamlab, Inc.
• Collaborator: Clionsky Neuro Systems Inc.
• Information provided by (Responsible Party): Pamlab, Inc.

Study Description

Brief 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.

Condition or disease
Mild Cognitive Impairment

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 Design

• Study Type: Observational
• Estimated Enrollment: 700 participants
• 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
• Study Start Date: January 2013
• Actual Primary Completion Date: August 2013
• Estimated Study Completion Date: April 2014

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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 ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Pamlab, Inc.
• ClinicalTrials.gov Identifier: NCT01594541
• Other Study ID Numbers: NAC-004
• First Posted: May 9, 2012
• Last Update Posted: March 24, 2014
• Last Verified: March 2014

Keywords provided by Pamlab, Inc.:

hyperhomocysteinemia; dementia; depression; vitamin B12; mild cognitive impairment; alzheimer's

Additional relevant MeSH terms:

Hyperhomocysteinemia; Cognitive Dysfunction; Neurocognitive Disorders; Mental Disorders; Cognition 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