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

Not Applicable

Recruiting

• Conditions: Alzheimers Disease

• Registration Number: NCT07177352
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-02
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-17
• Primary Completion: 2035-07-31
• Study Completion: 2035-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13000

Inclusion Criteria

- Report of objective or subjective memory concerns (by the participant and/or their informant) within the last year with or without a previous clinical diagnosis of MCI or dementia due to AD.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Concentration of pTau217 in Blood on Day1	Day 1
Cognitive score in ISLT on Day 1	Day 1

Trial Locations

Locations (102)

Sun Valley Research Center, Inc.; 🇺🇸 Imperial, California, United States

Inglewood Clinicals; 🇺🇸 Inglewood, California, United States

Irvine Center for Clinical Research; 🇺🇸 Irvine, California, United States

Healthy Brain Clinic; 🇺🇸 Long Beach, California, United States

Oakland Clinical; 🇺🇸 Oakland, California, United States

Riverside Clinical; 🇺🇸 Riverside, California, United States

Syrentis Clinical Research; 🇺🇸 Santa Ana, California, United States

Cenexel California Neuroscience Research, LLC; 🇺🇸 Sherman Oaks, California, United States

JEM Research LLC; 🇺🇸 Atlantis, Florida, United States

K2 Medical Research-Winter Garden; 🇺🇸 Clermont, Florida, United States

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