Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies (TRAVELLER)
Status and phase
Enrolling
Phase 3
Conditions
Alzheimers Disease
Treatments
Other: No Intervention
Details and patient eligibility
About
This study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.
Enrollment
80,000 estimated patients
Sex
All
Ages
50 to 90 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Screening
Allocation
N/A
Interventional model
Single Group Assignment
Masking
None (Open label)
80,000 participants in 1 patient group
Screening Arm
Other group
Description:
Participants will be assessed for their concentration of pTau217 in blood and cognitive score in the International Shopping List Test (ISLT).
Treatment:
Other: No Intervention
Trial contacts and locations
211
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Central trial contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry; Reference Study ID Number: WP45722 https://forpatients.roche.com/ No attachments to email below.
Data sourced from clinicaltrials.gov
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