Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements in Patients With Mild Cognitive Impairment, Alzheimer's Disease and Related Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pamlab, Inc.
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Change in rate of cognitive decline as measured by the Memory Performance Index (MPI)
研究概览
简要总结
In a retrospective analysis of data from 1100 patients, disease-delaying effects of Cerefolin®/CerefolinNAC® were examined in terms of cognition. The purpose of the current study is to expand the retrospective study dataset by prospectively collecting additional biomarker and imaging data.
详细描述
CerefolinNAC® is an orally administered prescription medical food, and is formulated as a combination of L-methylfolate calcium (as Metafolin®), methylcobalamin, and N-acetylcysteine. In a retrospective analysis, disease-delaying effects of Cerefolin®/CerefolinNAC® (CFLN) are examined in terms of cognition (measured by MCI Screen (MCIS)), and functional capacity (measured by Functional Assessment Staging Test (FAST)). - the treatment effect of CFLN on cognitive and functional measures, and on biomarker measures in patients with Alzheimer's disease and related disorders (ADRD).
The current study will expand the NAC-002b study dataset by prospectively collecting additional biomarker and imaging data in a more comprehensively assessed, matched sample of patients. This will allow more precise evaluation of cognitive and functional outcome measures, and biomarker measures will be assessed in an attempt to identify specific populations or conditions in which CFLN is most effective.
The sample will consist of patients with homocysteinemia plus past/current CFLN treatment (Treatment Group) matched to those without homocysteinemia plus no past/current B12, folate or CFLN treatment (Non-Treatment Group). Also 65 additional subjects will be recruited for the non-Treatment group, which will be used to improve the rate of decline estimates for the cognitive and functional outcome measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With a diagnosis of normal aging (NL), cognitive impairment or dementia not otherwise specified (CI/D), or ADRD
- •With at least one previous quantitative MRI (qMRI)
- •With at least one previous homocysteine level
- •Without homocysteinemia plus no past or current B12, folate or Cerefolin® treatment, OR with homocysteinemia plus past or current Cerefolin® treatment
排除标准
- •Subjects who do not meet the inclusion criteria will be excluded from the study.
结局指标
主要结局
Change in rate of cognitive decline as measured by the Memory Performance Index (MPI)
时间窗: Baseline to end of study (estimated average of 48 months)
Change in MPI over time will be calculated using multiple retrospective time points.
次要结局
- Change in rate of cognitive decline as measured by Trails A & B(Baseline to end of study (estimated average of 48 months))
- Change in rate of cognitive decline as measured by The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Drawings(Baseline to end of study (estimated average of 48 months))
- Rate of atrophy in cortical volume(Baseline to end of study (estimated average of 48 months))
- Change in rate of cognitive decline as measured by Functional Assessment Staging Test (FAST)(Baseline to end of study (estimated average of 48 months))
- Rate of atrophy of hippocampal volume(Baseline to end of study (estimated average of 48 months))
- Change in rate of cognitive decline as measured by the MCI Screen(Baseline to end of study (estimated average of 48 months))
- Rate of atrophy in ventricular volume(Baseline to end of study (estimated average of 48 months))