New Alzheimer's drug aims to clear brain plaques

NCT ID NCT04639050

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study tests an experimental drug called RO7126209 (Trontinemab) in people with early to moderate Alzheimer's disease. The drug is given by IV infusion and aims to reduce amyloid plaques in the brain, a hallmark of Alzheimer's. About 241 participants will receive either the drug or a placebo to check safety and how well the drug works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: RO7126209 (Trontinemab)
What this could lead to: If successful, this could point toward a treatment that slows or stops Alzheimer's by clearing amyloid plaques from the brain.
What could go wrong: This is an early-phase trial (Phase 1/2) with a small number of participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to show benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

241 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key inclusion criteria for part 1, 2 and 3: * Ability to provide written consent signed by the participant * Availability of a person (referred to as the "study partner") who: consents to participate throughout the duration of study, in the Investigator's judgment, has frequent and sufficient contact with the participant, is fluent in the language of the tests used at the study site * Willingness and ability to complete all aspects of the study (including magnetic resonance imaging \[MRI\], lumbar puncture, clinical genotyping, and positron emission tomography \[PET\] imaging) * Capable of completing assessments either alone or with the help of the study partner * Adequate visual and auditory acuity, in the Investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted) * Probable mild to moderate AD dementia (consistent with National Institute on Aging-Alzheimer's Association \[NIA-AA\] core clinical criteria for probable AD dementia) or prodromal AD (consistent with the NIA-AA diagnostic criteria and guidelines for mild cognitive impairment due to AD) * Screening Mini-Mental State Examination (MMSE) score of 18 to 28 points, inclusive, within 84 days before baseline * Clinical Dementia Rating-Global Score (CDR-GS) of 0.5, 1, or 2 within 84 days before baseline * Positive amyloid PET scan (cut-off: \>50 Centiloid units) within 12 months before baseline * In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least 8 weeks prior to baseline and until randomization * Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug * Agreement not to participate in other research studies for the duration of this study * Agree to apolipoprotein E (APOE) genotyping Inclusion criteria for Part 4: \- Completed the treatment period in Part 1, Part 2, or Part 3 of the study Key exclusion criteria for part 1, 2 and 3: * Any evidence of other relevant neurological condition, including other (non-AD) neurodegenerative and neuropsychiatric conditions, neurovascular brain disorders, seizure disorders, inflammatory and infectious disorders of the central nervous system, trauma and delirium, among several others * Other relevant medical conditions including significant hematological diseases, any clinically significant ophthalmologic diseases, decreased visual acuity in either eye, with a BCVA letter score of less than 20 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or the Snellen equivalent of 20/400 if the ETDRS chart is not used * Clinically significant cardiovascular diseases, chronic kidney disease, confirmed and unexplained impaired hepatic function, abnormal thyroid function, among several others * History of hypersensitivity to biologic agents or any of the excipients in the formulation * Clinically significant abnormalities (as judged by the Investigator) in laboratory test results (including complete blood count, chemistry panel, routine cerebrospinal fluid \[CSF\] parameters and urinalysis) * MRI exclusion criteria: \>2 lacunar infarcts (including lacunar infarcts in the cerebellum), any territorial infarct \>1 cm\^3, any white matter lesion that corresponds to an overall Fazekas score of 3 that requires at least one confluent hyperintense lesion on the fluid-attenuated inversion recovery (FLAIR) sequence, which is ≥20 mm in any dimension * More than 4 microhemorrhages on MRI and/or presence of any focal area of leptomeningeal hemosiderosis based on the review performed by the central MRI reader prior to randomization * Presence of any other significant cerebral abnormalities, including amyloid-related imaging abnormality-edema/effusion (ARIA-E), as assessed on MRI * Inability to tolerate MRI procedures or contraindication to MRI * Inability to undergo ophthalmological assessments * Contraindication to lumbar puncture * Contraindication to having a PET scan Exclusion criteria for Part 4: * Prematurely discontinued from the treatment period for study (i.e., before the start of the follow-up period of Part 1, Part 2, or Part 3) for any reason or meeting discontinuation criteria before the baseline visit of Part 4. * Received any active investigational treatment other than RO7126209 during or since completion of Part 1, Part 2 or Part 3 * Any passive immunotherapy (immunoglobulin) since completion of Part 1, Part 2, or Part 3 that is meant to prevent or postpone cognitive decline. * Use of anti-coagulation medications - Evidence of ongoing ARIA-E. In this case participant may enroll into Part 4 once the ARIA-E is resolved - Evidence of ongoing infusion-related reaction (IRR) or hypersensitivity reaction. In this case participant may enroll into Part 4 once the IRR is resolved. * MRI evidence of any of the following at OLE baseline: evidence of ongoing ARIA-E, any ARIA-H (leptomeningeal hemosiderosis or microhemorrhages) that would require permanent discontinuation of study treatment, \> 2 lacunar infarcts, Any territorial infarct \> 1 cm\^3, any white matter lesion that corresponds to an overall Fazekas score of 3 that requires at least one confluent hyperintense lesion on the FLAIR sequence, which is ≥ 20 mm in any dimension * Any drop in hemoglobin of \> 20% compared to predose on Day 1 or hemoglobin value below 10 g/dL

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimers disease

Contacts and locations

Locations

Abington Neurological Associates

Abington, Pennsylvania, 19001, United States
Alfred Hospital

Melbourne, Victoria, 3004, Australia
Alzheimer's Research and Treatment Center

Stuart, Florida, 34996, United States
Alzheimer's Research and Treatment Center - Columbus

Columbus, Georgia, 31904, United States
Alzheimer?s Research and Treatment Center

Wellington, Florida, 33414, United States
Center for Advanced Research & Education

Gainesville, Georgia, 30501, United States
Centro de Investigación Clínica UC-CICUC

Santiago, 8330034, Chile
Charter Research - Lady Lake/The Villages

The Villages, Florida, 32162, United States
Charter Research - Winter Park/Orlando

Orlando, Florida, 32803, United States
Conquest Research, LLC

Winter Park, Florida, 32789, United States
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Tokyo, 190-8531, Japan
Fundación ACE

Barcelona, 08028, Spain
Heidelberg Repatriation Hospital

Heidelberg West, Victoria, 3081, Australia
Hospital Clinic i Provincial

Barcelona, 08036, Spain
Hospital Clinico Univ de Chile

Santiago, 8380456, Chile
Hospital General De Catalunya

Sant Cugat del Vallès, Barcelona, 8195, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Dr. Peset

Valencia, 46017, Spain
Inha University Hospital

Incheon, 22332, South Korea
JEM Research LLC

Atlantis, Florida, 33462, United States
K2 Medical Research - The Villages

Lady Lake, Florida, 32159, United States
K2 Medical Research, LLC

Maitland, Florida, 32751, United States
K2 Medical Research-Winter Garden

Clermont, Florida, 34711, United States
Keio University Hospital

Tokyo, 160-8582, Japan
Kerwin Research Center, LLC

Dallas, Texas, 75231, United States
Koseikai Takeda Hospital

Kyoto, 600-8558, Japan
NZOZ WCA

Wroc?aw, 53-659, Poland
National Hospital Organization Utano National Hospital

Kyoto, 616-8255, Japan
Optimus U Corp

Miami, Florida, 33135, United States
Osrodek Badan Klinicznych Euromedis

Szczecin, 70-111, Poland
Policlínica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Quest Research Institute

Farmington Hills, Michigan, 48334, United States
Richmond Clinical Trials

Richmond, British Columbia, V6V 2L1, Canada
Samsung Medical Center

Seoul, 06351, South Korea
Tokyo Metropolitan Institute for Geriatrics and Gerontology

Tokyo, 173-0015, Japan
Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada
UCL Institute of Neurology

London, WC1N 3BG, United Kingdom

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