A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients

NCT01594541 | Unknown

• 1 other identifier: NAC-004
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

Patients Treated with CerefolinNAC®

Patients Not Treated with CerefolinNAC®

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamlab, Inc.: lead
• Clionsky Neuro Systems Inc.: collaborator

Study Sites (1)

Clionsky Neuro Systems, Inc.

Springfield, Massachusetts, 01105, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Hyperhomocysteinemia; Dementia; Depression

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Emily Clionsky, MD

  Clionsky Neuro Systems Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: May 9, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: April 1, 2014
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

US (1)