Development of a Home Test for Measuring Blood P-tau217 in Alzheimer's Disease Using the Tasso Lancet Device
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-90
SponsorNeurogen Biomarking LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Uncontrolled systemic conditions Recent surgery/hospitalization (3 months) Other dementia drug trial (2 months) Pregnancy Prior Donanemab or Lecanemab use
Trial population
Adults aged 40-90 recruited through clinical records review, advertising, and community outreach, including AD patients, cognitively healthy controls, and non-AD cognitively impaired individuals with confirmed amyloid-negative status. A subset has amyloid pathology confirmed via PET or CSF.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 3 trial groupsGroup A: AD subjects
Group B: Healthy Controls
Group C: Non-AD cognitively impaired (amyloid-negative)
Trial outcomes
Primary outcomes
1
Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood
Mean, mean fold-change, and effect size of p-tau217 in Tasso samples between AD and non-AD groups.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov