NCT07701161招募中不适用
Development of a Home Test for Measuring Blood P-tau217 in Alzheimer's Disease Using the Tasso Lancet Device
Neurogen Biomarking LLC5 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年1月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood
研究概览
简要总结
This study compares p-tau217 concentrations in blood collected via the Tasso device versus standard venipuncture in subjects with and without Alzheimer's disease, including a subset with confirmed amyloid pathology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AD Amyloid PET/CSF confirmed, healthy control, or amyloid-negative non-AD cognitive impairment Age 40-90 Able to complete Tasso and venipuncture collection Caregiver consent/assistance available if needed
排除标准
- •Uncontrolled systemic conditions Recent surgery/hospitalization (3 months) Other dementia drug trial (2 months) Pregnancy Prior Donanemab or Lecanemab use
研究组 & 干预措施
AD subjects
Amyloid PET/CSF confirmed and clinically diagnosed
Healthy Controls
No history of cognitive impairment
Non-AD cognitively impaired (amyloid-negative)
Cognitive impairment not due to AD, confirmed amyloid-negative via PET/CSF
结局指标
主要结局
Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood
时间窗: Baseline
Mean, mean fold-change, and effect size of p-tau217 in Tasso samples between AD and non-AD groups.
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
相似试验
招募中
不适用
Blood-based Biomarkers for Alzheimer's Disease at the Primary Care Level.NCT07666113Universitaire Ziekenhuizen KU Leuven240
尚未招募
不适用
Study on the Effectiveness and Safety of a Skincare Product.CTRI/2025/01/079298Alembic Pharmaceuticals Ltd.36
尚未招募
不适用
A study to validate BTL-001-2 ABPM Blood Pressure instrument.CTRI/2024/11/076934BTL India Pvt Ltd114
Unknown
不适用
华西血浆指标研究阿尔茨海默症ChiCTR2100042106四川大学华西医院卓越学科项目(ZY2016103，ZY2016203）500
尚未招募
不适用
Validation of Different Methods for HepQuant DuO® Blood Sample CollectionNCT07473817HepQuant, LLC200