Mild Cognitive Impairment
Conditions
Keywords
hyperhomocysteinemia, dementia, depression, vitamin B12, mild cognitive impairment, alzheimer's
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.
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
Interventions
None listed
Sponsors
Clionsky Neuro Systems Inc.
Pamlab, Inc.
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Levels of Homocysteine Over Time | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed