Effect of Gantenerumab on amyloid PET SUVr in patients with early Alzheimer's disease (AD)

A Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the effect of Gantenerumab on amyloid PET SUVr in patients with early (prodromal to mild) Alzheimer's disease(AD)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224569

Enrollment

Registered

2019-02-22

Start date

2019-07-22

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

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: - Evidence of amyloid pathology as indicated by a positive result on central reading of an amyloid PET scan using flutemetamol (18F) - 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) - MMSE score greater than or equal to 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 - ARIA-E or any other significant cerebral abnormalities

Design outcomes

Primary

Measure	Time frame
pharmacodynamics Observation/examination	—

Secondary

Measure	Time frame
efficacy Observation/examination	—

Countries

Japan

Outcome results

None listed

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