Hyperhomocysteinemia in a Mild Cognitive Impairment and Dementia Population: the Effect of Treatment With Cerefolin NAC® in a Naturalistic Community-based Dementia Practice
试验速览
- 阶段
- 不适用
- 发起方
- Pamlab, Inc.
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Change from Baseline in Levels of Homocysteine Over Time
研究概览
简要总结
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.
详细描述
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:
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Wechsler Memory Scale-Revised (WMS-R) or Fourth Edition (WMS-IV)
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Logical Memory -Delayed Recall, Scaled Score
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Visual Reproduction-Delayed Recall, Scaled Score
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Shopping List Test, Delayed Recall
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Trailmaking A and B Tests
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Verbal Absurdities subtest of the Stanford Binet, Form L-M
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Proverbs Test
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Memory Orientation Screening Test
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Folstein Mini-Mental State Exam
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Geriatric Depression Scale, 15 items
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 55 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from Baseline in Levels of Homocysteine Over Time
时间窗: 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.
次要结局
- 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)