Evidence map›Paper›PMID 40302041›Full record

Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2025

Japanese participant data from three gantenerumab trials in early Alzheimer's disease.

Takashi Asada, Angeliki Thanasopoulou, Paul Delmar, Jakub Wojtowicz, Janice Smith, Yasumasa Yoshiyama, Katsunori Yokoi, Chigusa Watanabe, Mitsuhiro Isozaki, Ryoto Ozaki and 3 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03443973 phase3terminatednot on this map

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

TypeinterventionalSponsorHoffmann-La RocheRan2018 to 2022Enrolled975ConditionsAlzheimer DiseaseArmsGantenerumab, Placebo
NCT03444870 phase3terminatednot on this map

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

TypeinterventionalSponsorHoffmann-La RocheRan2018 to 2023Enrolled1,053ConditionsAlzheimer DiseaseArmsGantenerumab, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Japanese participant data from three gantenerumab trials in early Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Trial
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Takashi AsadaInstitute of Science Tokyo, Tokyo, Japan.ORCID 0009-0003-4621-9366
Angeliki ThanasopoulouRoche Product Development, Neuroscience, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Paul DelmarRoche Product Development, Neuroscience, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Jakub WojtowiczRoche Product Development, Neuroscience, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Janice SmithProduct Development, Roche Products Ltd, Welwyn Garden City, UK.
Yasumasa YoshiyamaInage Neurology and Memory Clinic, Chiba, Japan.
Katsunori YokoiDepartment of Neurology, National Center for Geriatrics and Gerontology, Obu, Japan.
Chigusa WatanabeDepartment of Neurology, National Hospital Organization Hiroshima-Nishi Medical Center, Hiroshima, Japan.
Mitsuhiro IsozakiMemory Clinical Toride, Toride, Japan.
Ryoto OzakiBiometrics Department, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Takaaki IshidaPharmaceutical Science Department, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Hironori TatsudaSpecialty Clinical Development Department, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Akira TamaokaDepartment of Neurology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.

Funding

Chugai PharmaceuticalF. Hoffmann-La Roche
6 · The paper itself

Abstract

introductionGantenerumab was investigated in Japanese participants with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD in two global phase 3 trials (GRADUATE I/II), and a phase 2 trial in Japan (JP40959).

methodsOf 1965 participants randomized in GRADUATE I/II (global-GRADUATE), 132 participants were enrolled from Japan (Japanese-GRADUATE) and 67 Japanese participants were randomized 2:1:1 to high-, low-dose gantenerumab, and placebo in JP40959.

resultsSlowing of cognitive and functional decline, and amyloid reduction in gantenerumab group compared to placebo group were greater in Japanese-GRADUATE than in the global-GRADUATE and JP40959. Plasma gantenerumab concentrations in the Japanese-GRADUATE were slightly higher than in the global-GRADUATE and comparable to JP40959. Gantenerumab was well tolerated in the Japanese-GRADUATE and JP40959, matching the safety profile of the global-GRADUATE. DISCUSSION: Differences in results across the populations studied could be related to imbalances in baseline body weight, amyloid load, and disease severity. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID: NCT03444870, NCT03443973; Japan Registry for Clinical Trials ID: jRCT2080224569. HIGHLIGHTS: Gantenerumab was evaluated in Japanese participants with Alzheimer's disease (AD) in two global phase 3 trials and a phase 2 trial in Japan. Relative reduction in Clinical Dementia Rating Sum of Boxes (CDR-SB) deterioration favored gantenerumab in Japanese-GRADUATE (42%) more than in global-GRADUATE (9%) and JP40959 (-24%). Amyloid reduction in Japanese-GRADUATE was greater than in global-GRADUATE and JP40959. Overall, 72.7% and 27.5% of Japanese- and global-GRADUATE, respectively, achieved an amyloid-negative status. Cognitive and functional decline, and amyloid reduction could be related to baseline body weight and disease severity.

Indexed as

Alzheimer DiseaseAntibodies, Monoclonal, HumanizedCognitive DysfunctionAgedAmyloid beta-PeptidesDouble-Blind MethodEast Asian PeopleFemaleHumansJapanMaleTreatment OutcomeAmyloid beta-PeptidesAntibodies, Monoclonal, HumanizedgantenerumabAlzheimer's diseaseamyloid positron emission tomographyanti‐amyloid betaearly Alzheimer's diseasegantenerumabGRADUATE IGRADUATE IIJapanese Alzheimer's disease participantsJP40959mild Alzheimer's diseasemild cognitive impairmentmild cognitive impairment due to Alzheimer's diseasemild dementiaprodromal Alzheimer's disease

Identifiers

PMID40302041
PMCPMC12040720

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.