NCT07701161RecruitingNot Applicable
Development of a Home Test for Measuring Blood P-tau217 in Alzheimer's Disease Using the Tasso Lancet Device
Neurogen Biomarking LLC5 sites in 1 country1,000 target enrollmentStarted: January 13, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 5
- Primary Endpoint
- Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Uncontrolled systemic conditions Recent surgery/hospitalization (3 months) Other dementia drug trial (2 months) Pregnancy Prior Donanemab or Lecanemab use
Arms & Interventions
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
Outcomes
Primary Outcomes
Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood
Time Frame: Baseline
Mean, mean fold-change, and effect size of p-tau217 in Tasso samples between AD and non-AD groups.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
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