A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)

Sponsor
Hoffmann-La Roche
Study ID
NCT07234942
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • RO7812653 — DRUG
    Participants will receive RO7812653 as per the schedule in the protocol
  • Placebo — DRUG
    Participants will receive placebo as per the schedule in the protocol

Study Details

This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.

Key Dates

First listed
Nov 19, 2025
Start date
Jan 27, 2026
Status verified
Jun 2026
Primary completion
Apr 19, 2028
Completion
Mar 5, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RO7812653
    Participants will receive a dose of RO7812653
  • Placebo Comparator: Placebo
    Participants will receive a dose of placebo

Primary Outcome Measure

Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 40 weeks ]

Central Contacts

  • Reference Study ID Number: BP45770 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

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