NCT06622135终止不适用
Development of a Home Test for Measuring Plasma P-tau217 in Alzheimer's Disease Using Tasso Lancet Device
Insight Research Institute4 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年9月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Agreement between measurements of P-tau217 concentration in blood samples from Tasso device and venipuncture
研究概览
简要总结
The goal of this is to develop an easy at home test that can be used to assist in diagnosing Alzheimer's disease (AD). The test will use an FDA approved device for at home blood sample collection. The blood samples will be evaluated to determine if the concentration of p-tau217, a biomarker that is elevated in AD patients, measured from blood samples collected using the at home device is comparable to the results obtained from blood samples collected by venipuncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with Alzheimer's Disease Only: diagnosed according the NIA-AA diagnostic AD criteria
- •Healthy Control Only: Subject does not have history of cognitive impairment
- •55 - 90 years old
- •Subject able to comply with study procedures
- •Subjects must be able to use the Tasso device for blood sample collection as per the provided instructions (can be performed with the assistance of a caregiver)
- •Subjects must be able to undergo IV sampling
- •Have a study partner who will provide written informed consent to participate, and assist with blood collection when applicable
排除标准
- •Subjects with systemic conditions which were not adequately controlled through a stable medication regimen
- •Subjects with any known significant bleeding disorders or conditions that contraindicate blood sample collection (e.g., hemophilia, severe thrombocytopenia)
- •Subjects with a known history of severe skin allergies or reactions to adhesives (since the Tasso device involves adhesive application to the skin)
- •Subjects currently taking anticoagulant or antiplatelet medications that could interfere with blood collection or increase the risk of complications
- •Subjects who have undergone major surgery or have been hospitalized for any reason in the last 3 months prior to study enrollment
- •Participation in a clinical study within the 2 month
结局指标
主要结局
Agreement between measurements of P-tau217 concentration in blood samples from Tasso device and venipuncture
时间窗: Day 1
次要结局
- Means of p-tau217 concentration in subjects with and without AD(Day 1)
- Agreement between measurements of P-tau217 concentration by the ALZpath P-tau217 and Janssen P-tau217+ assays(Day 1)
- Percentage of Tasso devices which are loss, damaged, or with inadequate blood volume for analysis(Day 1)
- Mean fold-change of p-tau217 concentration in subjects with and without AD(Day 1)
- Effect size of p-tau217 concentration in subjects with and without AD(Day 1)
研究者
Abeer Gharaibeh
Director of Research
Insight Research Institute
研究点 (4)
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