A Study of Gantenerumab in Patients With Mild Alzheimer Disease

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222585

Enrollment

389

Registered

2014-08-20

Start date

2014-10-22

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

Alzheimers 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: - Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved medication - Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities - Fluency in the language of the tests used at the study site - PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2

Exclusion criteria

Exclusion criteria: - Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia - History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months - Part 2 Participants who have been discontinued from the study

Design outcomes

Primary

Measure	Time frame
safety efficacy Observation/examination	—

Secondary

Measure	Time frame
safety efficacy Observation/examination	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania

Outcome results

None listed

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