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Alzheimer's DiseasePhase 3PrevenTRONNCT07717411

A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

A Phase 3 study testing Trontinemab in people with Alzheimer's Disease, run by Hoffmann-La Roche at 72 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD. Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Trontinemab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,600 participants
Where
72 sitesin 10 countries
Study dates
2 Oct 2026to 3 Sep 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body weight of 150 kg or less
  • Willingness and ability to complete all aspects of the study for the duration of the study
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
  • Cognitively and functionally unimpaired as defined by the protocol
  • Availability of a study partner as defined by the protocol
  • A plasma pTau217 level consistent with a high likelihood of future clinical progression

Who cannot join

  • Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson disease, corticobasal syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal lobar degeneration (other than frontotemporal dementia), Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium, or hypoxia
  • Mild cognitive impairment (MCI; may be referred to as prodromal AD), or any form of dementia
  • History or presence of clinically significant cerebrovascular disease
  • History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
  • History or presence of clinically significant intracranial mass
  • History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
Show all 28Show fewer
  • History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 12 months of an acute event that is consistent, in the opinion of the PI, with a transient ischemic attack
  • At risk for suicide in the opinion of the investigator
  • Substance abuse disorder within 12 months prior to screening (nicotine use is allowed)
  • Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments
  • Uncontrolled hypertension
  • Impaired hepatic function
  • History or presence of any clinically significant hematological diseases
  • Diagnosis of a wet age-related macular degeneration (AMD)
  • Abnormal thyroid function
  • Abnormally low serum levels of folic acid or vitamin B12 deficiency that are judged to be clinically significant and/or may impact cognition as per the investigator's judgment
  • Current HIV, hepatitis B, or hepatitis C infection that has not been adequately treated in the opinion of the investigator
  • History of malignancy
  • Any previous administration of active immunotherapy (vaccine) that is being evaluated to prevent or postpone cognitive decline
  • Any previous or current use of passive immunotherapy (immunoglobulin) or other long-acting biologic agent that is approved or under evaluation or has been evaluated to prevent or postpone cognitive decline
  • Any other investigational treatment within 5 half-lives or 4 months prior to screening, whichever is longer
  • Intravenous (IV) or subcutaneous immunoglobulin therapy within 5 half-lives or 4 months prior to baseline whichever is longer
  • Anticoagulation medications at screening and there should be no plans to initiate any prior to or after randomization
  • Any treatment with cholinesterase inhibitors
  • Antipsychotic or neuroleptic medications within 3 months of screening, except as brief treatment for a non-psychiatric indication
  • Individuals with chronic use of opiates or opioids, benzodiazepines, barbiturates, or hypnotics, antidepressants or medication to treat anxiety should be on a stable dose for at least 8 weeks before baseline
  • Currently enrolled in an interventional study including those requiring investigational medicinal product (IMP) or involving any type of medical research that may interfere with study cognitive assessments
  • Residence in a skilled nursing facility such as a convalescent home or long-term care facility

Trial locations and contacts

72 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: WN46072 https://forpatients.roche.com contact

1-888-662-6728

global-roche-genentech-trials@gene.com

72 sites in 10 countries

United States24 sites, 24 recruiting

  • Sana Research, LLC

    Arlington, Virginia, 22205

    Recruiting

  • Adams Clinical Boston

    Boston, Massachusetts, 02116

    Recruiting

  • Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville

    Chicago, Illinois, 60640

    Recruiting

  • Alzheimer's Research and Treatment Center - Columbus

    Columbus, Georgia, 31904

    Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

    Recruiting

  • Irvine Center for Clinical Research

    Irvine, California, 92614

    Recruiting

  • Basil Clinical

    Laurelton, New York, 11413-2016

    Recruiting

  • Healthy Brain Clinic

    Long Beach, California, 90804

    Recruiting

  • Inglewood Clinicals

    Los Angeles, California, 90056

    Recruiting

  • K2 Medical Research, LLC

    Maitland, Florida, 32751

    Recruiting

  • Boston Center for Memory

    Newton, Massachusetts, 02459

    Recruiting

  • Oakland Clinical

    Oakland, California, 94609

    Recruiting

  • Renstar Medical Research

    Ocala, Florida, 34470

    Recruiting

  • Charter Research - Winter Park/Orlando

    Orlando, Florida, 32803

    Recruiting

  • Conquest Research - Lake Nona

    Orlando, Florida, 32832

    Recruiting

  • National Clinical Research Inc.-Richmond

    Richmond, Virginia, 23294

    Recruiting

  • Riverside Clinical

    Riverside, California, 92506

    Recruiting

  • Syrentis Clinical Research

    Santa Ana, California, 92705

    Recruiting

  • Cenexel California Neuroscience Research, LLC

    Sherman Oaks, California, 91403

    Recruiting

  • Alzheimer's Research and Treatment Center

    Stuart, Florida, 34996

    Recruiting

  • Charter Research - Lady Lake/The Villages

    The Villages, Florida, 32162

    Recruiting

  • Adams Clinical Watertown

    Watertown, Massachusetts, 02472

    Recruiting

  • Alzheimer?s Research and Treatment Center

    Wellington, Florida, 33414

    Recruiting

  • Conquest Research, LLC

    Winter Park, Florida, 32789

    Recruiting

Other trials in United States

China18 sites, 18 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Recruiting

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    Beijing, 100050

    Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053

    Recruiting

  • the First Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

    Recruiting

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, 510115

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330038

    Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210003

    Recruiting

  • Nanjing Brain Hospital

    Nanjing, 210029

    Recruiting

  • Nanjing First Hospital

    Nanjing, 210029

    Recruiting

  • Tongji Hospital of Tongji University

    Shanghai, 200065

    Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031

    Recruiting

  • The Second Affiliated Hospital of Suzhou University

    Suzhou, 215025

    Recruiting

  • Shaanxi Provincial People's Hospital

    Xi'an, 710068

    Recruiting

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, 710077

    Recruiting

  • Yan'an University Xianyang Hospital

    Xianyang, Shaanxi, 712000

    Recruiting

Other trials in China

Japan7 sites, 7 recruiting

  • National Center for Geriatrics and Gerontology

    Aichi, 474-8511

    Recruiting

  • Kobe University Hospital

    Hyōgo, 650-0017

    Recruiting

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Tokyo, 104-0031

    Recruiting

  • Clinical Research Hospital Tokyo

    Tokyo, 160-0004

    Recruiting

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

    Recruiting

  • Higashi-Shinjuku Clinic

    Tokyo, 169-0072

    Recruiting

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    Tokyo, 173-0015

    Recruiting

Other trials in Japan

United Kingdom7 sites, 7 recruiting

  • Scottish Brain Sciences

    Aberdeen, AB25 2XE

    Recruiting

  • Re:Cognition Health Birmingham

    Birmingham, B16 8QQ

    Recruiting

  • Surrey and Borders NHS Foundation Trust

    Chertsey, KT16 9AU

    Recruiting

  • Scottish Brain Sciences

    Edinburgh, EH12 5PJ

    Recruiting

  • Re:Cognition Health London

    London, W1G 8TB

    Recruiting

  • Charing Cross Hospital

    London, W6 8RF

    Recruiting

  • Moorgreen Hospital

    Southampton, SO30 3JB

    Recruiting

Other trials in United Kingdom

Canada6 sites, 6 recruiting

  • Kelowna Health and Memory Centre Ltd.

    Kelowna, British Columbia, V1Y 5A8

    Recruiting

  • Genge Partners Inc.

    Montreal, Quebec, H4A 3T2

    Recruiting

  • Kawartha Regional Memory Clinic

    Peterborough, Ontario, K9H 2P4

    Recruiting

  • Alpha Recherche Clinique

    Québec, G3K 2P8

    Recruiting

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

    Recruiting

  • Centricity Research Toronto

    Toronto, Ontario, M4G 3E8

    Recruiting

Other trials in Canada

Taiwan3 sites, 3 recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

  • Taipei Medical University ?Shuang Ho Hospital

    Zhonghe Dist., 23561

    Recruiting

Other trials in Taiwan

Argentina2 sites, 2 recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

    Recruiting

  • INECO Neurociencias Orono

    Rosario, Santa Fe Province, S2000DTC

    Recruiting

Other trials in Argentina

Australia2 sites, 2 recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    Recruiting

  • KaRa Institute of Neurological Diseases

    Macquarie Park, New South Wales, 2113

    Recruiting

Other trials in Australia

Brazil2 sites, 2 recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

    Recruiting

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

    Recruiting

Other trials in Brazil

Chile1 site, 1 recruiting

  • Clínica MEDS

    Santiago, 7691236

    Recruiting

Other trials in Chile

About this study

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.

Being tested
Trontinemab, Placebo
Keywords
Alzheimer's, Alzheimer's Disease, pre-clinical
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrontinemabDrug

    Participants will receive IV trontinemab.

  • PlaceboDrug

    Participants will receive IV placebo.

Study groups in NCT07717411
Study groupRoleWhat they receive
TrontinemabExperimentalParticipants will receive intravenous (IV) trontinemab.
Receives: Drug: Trontinemab
PlaceboPlacebo comparatorParticipants will receive IV placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0

    Measured: Baseline up to approximately 6 years

Secondary outcomes (19)

  1. Change from Baseline through Week 216 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)

    Measured: Baseline through Week 216

  2. Change from Baseline through Week 216 in Free and Cued Selective Reminding Test (FCSRT) total recall score

    Measured: Baseline through Week 216

  3. Change from Baseline through Week 216 in Digit Symbol Substitution Test (DSST) coding score

    Measured: Baseline through Week 216

  4. Change from Baseline through Week 216 in Cognitive Function Instrument (CFI) study partner, total score

    Measured: Baseline through Week 216

  5. Change from Baseline through Week 216 in Category fluency total score

    Measured: Baseline through Week 216

  6. Change from Baseline through Week 216 in Mini-Mental State Examination (MMSE) total score

    Measured: Baseline through Week 216

  7. Change from Baseline through Week 216 in Wechsler Memory Scale, Logical Memory II Delayed Paragraph Recall (WMS LM II [DR]) score

    Measured: Baseline through Week 216

  8. Change from Baseline through Week 216 in Amsterdam Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV) study partner, total score

    Measured: Baseline through Week 216

  9. Change from Baseline through Week 216 in Trail Making Test (TMT)

    Measured: Baseline through Week 216

  10. Time to progression to adjudicated mild cognitive impairment (MCI) diagnosis

    Measured: Baseline up to approximately 6 years

  11. Incidence of adverse events

    Measured: Baseline up to approximately 6 years

  12. Frequency of amyloid-related imaging abnormalities-edema/effusion (ARIA-E) and amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H) magnetic resonance imaging (MRI) findings

    Measured: Baseline up to approximately 6 years

  13. Severity of ARIA-E and ARIA-H MRI findings

    Measured: Baseline up to approximately 6 years

  14. Frequency of infusion-related reactions (IRRs)

    Measured: Baseline up to approximately 6 years

  15. Severity of IRRs

    Measured: Baseline up to approximately 6 years

  16. Incidence of anti-drug antibodies (ADAs) to trontinemab

    Measured: Baseline up to approximately 6 years

  17. Change from baseline through Week 216 in brain amyloid load, as measured by amyloid positron emission tomography (PET) scan

    Measured: Baseline through Week 216

  18. Change from baseline through Week 216 in blood biomarker phosphorylated tau 217 (pTau217)

    Measured: Baseline through Week 216

  19. Change from baseline through Week 216 in blood biomarker glial fibrillar acidic protein (GFAP)

    Measured: Baseline through Week 216

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start2 Oct 2026
  3. Primary completion30 Jul 2032 (estimated)
  4. Study completion3 Sep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07717411
Sponsor's protocol ID
WN46072
Acronym
PrevenTRON
Status last verified
Nov 2026
First submitted
17 Jul 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trontinemab in people with Alzheimer's Disease, run by Hoffmann-La Roche at 72 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, China, Japan, United Kingdom, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: WN46072 https://forpatients.roche.com (1-888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0 (time frame: Baseline up to approximately 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07717411.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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