This trial is active, not recruiting.

Condition mild cognitive impairment
Sponsor Pamlab, Inc.
Collaborator Clionsky Neuro Systems Inc.
Start date January 2013
End date August 2013
Trial size 700 participants
Trial identifier NCT01594541, NAC-004


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective retrospective

Primary Outcomes

Change from Baseline in Levels of Homocysteine Over Time
time frame: Week 6, Week 12, and Quaterly Thereafter @ 6 Month Intervals

Secondary Outcomes

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
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

Male or female participants from 55 years up to 89 years old.

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

Additional Information

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
Principal investigator Emily Clionsky, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Pamlab, Inc..