Recruiting NCT07177352

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

Phase III Interventional Alzheimers Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: No Intervention.
Who it may be relevant to: Registry conditions: Alzheimers Disease. Basic parameters: 50 years — 90 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Canada +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Master Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies as Assessed by Biomarker Status and Cognition

Overview

This study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.

Interventions

Other No Intervention
Participants will have their blood drawn and cognitive score measured by the ISLT.

Primary outcome measures

Concentration of pTau217 in Blood on Day1 [Time frame: Day 1]
Cognitive score in ISLT on Day 1 [Time frame: Day 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Screening