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A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)

NCT05256134 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-06-12

Study results available
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Summary

A study to evaluate the efficacy and safety of gantenerumab in amyloid-positive, cognitively unimpaired participants at risk for or at the earliest stages of AD. The planned number of participants for this study is approximately 1200 participants randomized in a 1:1 ratio to receive either gantenerumab or placebo (600 participants randomized to gantenerumab and 600 participants randomized to placebo).

Conditions

  • Alzheimers Disease

Interventions

DRUG

Gantenerumab

Gantenerumab will be administered as per the dosing schedule described in the Arm description.

DRUG

Placebo

Placebo will be administered as per the dosing schedule described in the Arm description.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-03-13
Completion
2023-03-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Italy
  • Poland
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05256134 on ClinicalTrials.gov