Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223909

Enrollment

1016

Registered

2018-05-22

Start date

2018-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Interventions

investigational material(s) Generic name etc : Gantenerumab INN of investigational material : Gantenerumab Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Admi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment) - Evidence of the AD pathological process, as confirmed by CSF or amyloid PET scan - MMSE score greater than or equal to 22 (>=22) - CDR-Global score of 0.5 or 1.0

Exclusion criteria

Exclusion criteria: - Any evidence of a condition other than AD that may affect cognition - History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder - History or presence of clinically evident cerebrovascular disease - Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory Observation/examination	—

Secondary

Measure	Time frame
efficacy confirmatory Observation/examination	—

Countries

Asia except Japan, Europe, Japan, North America, other, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026