Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease

Sponsor
Hoffmann-La Roche
Study ID
NCT07781657
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • RO7568282 — DRUG
    RO7568282 will be administered as specified in the protocol.
  • Placebo — DRUG
    RO7568282 matching placebo will be administered as specified in the protocol.

Study Details

This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).

Key Dates

First listed
Aug 24, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Nov 1, 2029
Completion
Nov 1, 2029

Study Design

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

Arms

  • Experimental: RO7568282 High Dose
    Participants will receive high dose of RO7568282.
  • Experimental: RO7568282 Low Dose
    Participants will receive low dose of RO7568282.
  • Placebo Comparator: Placebo
    Participants will receive RO7568282 matching placebo.

Primary Outcome Measure

Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) [ Time Frame: From baseline up to Week 72 ]

Central Contacts

  • Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

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