DIGITAL Biomarker: Blood Based Biomarkers in the Primary Care Setting for Timely and Accurate Diagnosis of Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Patients who are willing to have Blood Based Biomarkers Performed
研究概览
简要总结
The primary objective of this study is to evaluate the feasibility of implementing blood-based biomarker testing for amyloid positivity designed to aid the early detection of Alzheimer's Disease and Related Dementia (ADRD) in patients 65+ including the rate that patients and providers follow up abnormal blood-based biomarker testing.
详细描述
This study is conducted to evaluate whether a new approach to screening patients for cognitive decline in primary care practices helps with earlier detection of Alzheimer's Disease. As part of the study, the provider subjects will receive training about the PrecivityAD blood biomarker test offered by C2N Diagnostics. They will be able to order the PrecivityAD test for possible Alzheimer's disease if their patient has an abnormal screening for cognitive impairment and consents to this study. Patient subjects will have their blood drawn (1 teaspoon) for the PrecivityAD blood test and will be asked to complete a surveys before and after the blood drawn. They will receive follow up phone calls within 1 to 4 weeks after they discuss the results of their blood test with their primary care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be > 65 years of age
- •Any gender
- •Is an established or new patient at one of the 6 participating IUHP PC sites
- •Is able to provide informed consent (research portion only for the biomarker consent) or has a Legally Authorized Representative (LAR) who can provide informed consent
- •Has a "red" DCA screening in the last 12 months (a score of 0 or 1 out of 5)
排除标准
- •Patients who do not complete a DCA screening for any reason
- •Existing diagnosis of dementia documented in their medical record based on ICD-10 codes
结局指标
主要结局
Number of Patients who are willing to have Blood Based Biomarkers Performed
时间窗: Mar 31, 2023 to May 31, 2023
Evaluate the feasibility and acceptability of implementing blood-based biomarker testing for Alzhiemer's Disease and Related Dementia in primary care practices
次要结局
未报告次要终点
研究者
Deanna Willis
Principal Investigator
Indiana University