Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies (TRAVELLER)

Roche

Status and phase: Enrolling; Phase 3

Conditions: Alzheimers Disease

Treatments: Other: No Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT07177352

WP45722

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