A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

Sponsor
Hoffmann-La Roche
Study ID
NCT07717411
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Trontinemab — DRUG
    Participants will receive IV trontinemab.
  • Placebo — DRUG
    Participants will receive IV placebo.

Study Details

This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.

Key Dates

First listed
Jul 21, 2026
Start date
Nov 30, 2026
Status verified
Jul 2026
Primary completion
Sep 3, 2032
Completion
Sep 3, 2032

Study Design

Enrollment
1,600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trontinemab
    Participants will receive intravenous (IV) trontinemab.
  • Placebo Comparator: Placebo
    Participants will receive IV placebo.

Primary Outcome Measure

Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0 [ Time Frame: Baseline up to approximately 6 years ]

Central Contacts

  • Reference Study ID Number: WN46072 https://forpatients.roche.com
    1-888-662-6728
    [email protected]

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