Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease… (NCT07177352) | Clinical Trial Compass
RecruitingPhase 3
Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies
United States, Argentina, Australia80,000 participantsStarted 2025-07-02
Plain-language summary
This study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ability and willingness to participate in an interventional clinical study, including meeting key eligibility criteria of linked interventional Roche AD studies (e.g., specific age ranges)
* Ability and willingness to receive information about potential eligibility in an associated interventional Roche AD study
Exclusion Criteria:
* Dependency in basic activities of daily living (bADLs) due to cognitive impairment
* Visual or auditory impairment that would prevent them from performing the cognitive assessments (eyeglasses and hearing aids are permitted)
* Any self-reported evidence or known diagnosis of a neurological or neurodegenerative condition that may lead to cognitive impairment other than AD
* History of severe, clinically significant central nervous system trauma
* Any serious medical condition that precludes a participant's safe participation and completion of a clinical study
* For participants with a clinical diagnosis of MCI or mild AD: Previous AD diagnosis based on biomarker confirmation with an approved or validated rule in method (e.g., amyloid PET or cerebrospinal fluid, blood biomarker) is exclusionary
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically measuring a blood marker called pTau217 and a memory test called the ISLT on the first day — can you explain what these two measurements are actually looking for, and whether my current test results or symptoms would likely make me a candidate worth discussing with the study team?
2Since this appears to be a screening study designed to identify people who might qualify for future Alzheimer's trials rather than a treatment study itself, can you help me understand what would happen next if my pTau217 levels or ISLT score put me in a certain range — would I automatically be directed toward another Phase 3 trial, and what would that involve?
3pTau217 is a relatively new blood-based biomarker for Alzheimer's — how confident are you in what a high or abnormal result would actually mean for my diagnosis or prognosis, and should I be prepared for results that might be uncertain or hard to interpret?
4Given that this is a Phase 3 level program focused on screening, are there standard diagnostic evaluations or treatments I should consider first before enrolling in a screening study like this, or could participating here actually help clarify my diagnosis faster than the usual path?
5The study involves assessments on Day 1, but could participation in this screening program affect my eligibility for other Alzheimer's treatment studies or standard care options down the road, and is there anything I should watch out for before agreeing to be screened?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of pTau217 in Blood on Day1
Timeframe: Day 1
2
Cognitive score in ISLT on Day 1
Timeframe: Day 1
Trial details
NCT IDNCT07177352
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2035-07-31
Contact for this trial
Reference Study ID Number: WP45722 https://forpatients.roche.com/ No attachments to email below.