Alzheimer’s disease Alzheimer’s disease
Conditions
Interventions
Elecsys® Phospho-Tau (217P) Plasma Assay
Sponsors
Roche Diagnostics International Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male or Female from 50 to 89 years old (inclusive) with cognitive concerns or with confirmed AD who are mentally competent (participants must be able to give the informed consent by themselves)
Exclusion criteria
Exclusion criteria: •Any woman who is pregnant or breastfeeding • The participant has received or is receiving any investigational treatment within 5 half-lives or 6 months (whichever is longer) prior to sample collection • Any participant who is receiving any anti-amyloid treatment • Any participant who is placed in an institution by court or official order or under supervision of a legal guardian • Contraindication** for donation of 45mL whole blood as judged by the investigator. **Contraindication criteria for the blood donation are e.g. (but not limited to) severe skin conditions, swelling or edema at puncture site, lymphedema, severe blood clotting disorders, anemia (haemoglobin concentration of < 12 g/dl for women and < 13 g/dl for men), acute inflammation at the injection site, allergies to disinfectants or other materials used in this context (latex, plasters).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoints Stability Condition 25°C Acceptable temperature range 23°C to 27°C Target stability claim 2 days Stability measured in study 3 daysStability Condition 2-8 °C Acceptable temperature range 2-8 °C Target stability claim 7 days Stability measured in study 8 days Stability Condition -20°C Acceptable temperature range -20 °C (± 5 °C) Target stability claim 12 weeks Stability measured in study 13 weeks Stability Condition Freeze / Thaw (- 20°C/ 20 °C) Acceptable temperature range -20 °C (± 5 °C)/ 15°C to 25°C Target stability claim 1 cycle Stability measured in study 1 cycle | — |
Countries
Netherlands
Contacts
Public ContactNMJ Miljanovic Jovanovic
Roche Diagnostics International Ltd
Outcome results
None listed