A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Conditions

• Alzheimers Disease

Eligibility Criteria

Sex

ALL

Age

50 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

Key Dates

Start date

Sep 17, 2025

Status verified

Jun 2026

Primary completion

Jun 7, 2028

Completion

Jun 7, 2028

Study Design

Enrollment

800 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

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

Central Contacts

• Reference Study ID Number: WN45443 https://forpatients.roche.com/
  888-662-6728
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (35)

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