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| Name | Class |
|---|---|
| Clionsky Neuro Systems Inc. | INDUSTRY |
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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.
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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Treated with CerefolinNAC® | |||
| Patients Not Treated with CerefolinNAC® |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss.
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| Name | Affiliation | Role |
|---|---|---|
| Emily Clionsky, MD | Clionsky Neuro Systems Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clionsky Neuro Systems, Inc. | Springfield | Massachusetts | 01105 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D020138 | Hyperhomocysteinemia |
| D003704 | Dementia |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000592 | Amino Acid Metabolism, Inborn Errors |
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| Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |