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Alzheimer's DiseasePhase 2NCT06402838

A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)

A Phase 2 study testing RO7269162 in people with Alzheimer's Disease, run by Hoffmann-La Roche at 46 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This clinical trial is recruiting people who either are at risk of AD - have build-up of beta-amyloid, but have no clinical symptoms, or with a diagnosis of mild cognitive impairment. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
RO7269162
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
256 participants
Where
46 sitesin 9 countries
Study dates
2 May 2024to 19 Nov 2026
Phase
Phase 2
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 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body Mass Index (BMI) between 18 to 35 kg/m^2 inclusive at screening
  • Participants must be either cognitively unimpaired or with a diagnosis of MCI due to AD, according to the National Institute on Aging - Alzheimer's Association (NIA - AA) research framework
  • Clinical Dementia Rating-Global Score (CDR-GS) of 0 or 0.5
  • Positive amyloid PET scan based on a cut-off of ≥24 CL units
  • Availability of a person (referred as a "study partner" throughout the protocol) who: (a) has frequent and sufficient contact (e.g., minimum twice a week in-person, via telephone, video calls, by e-mail or other electronic means) with the participant, and is willing and able to provide accurate information regarding the participant's cognitive and functional abilities, signs the necessary ICF(s), and has sufficient cognitive capacity to accurately report on the participant's cognitive and functional abilities; (b) is in sufficient good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the duration of the study; and (c) is fluent in the language of the tests used at the study site. Please note that the study partner does not need to be a family member. Every effort should be made to keep the same study partner throughout the study
  • In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least eight weeks prior to baseline

Who cannot join

  • Any medical history or evidence of a condition other than AD that may affect cognition
  • History or presence of significant cardiovascular conditions and/or significant hematological disease
  • History or presence of chronic kidney disease and/or impaired hepatic function
  • Uncontrolled/poorly controlled diabetes
  • History of or active inflammatory bowel disease
  • Have received any passive or active immunotherapy (immunoglobulin) or other long-acting biologic agent that is under evaluation or approved to prevent or postpone cognitive decline administered within 1 year prior to baseline, and/or any other investigational treatment within five half-lives or 16 weeks prior to screening, whichever is longer

Trial locations and contacts

46 sites in 9 countries.

46 sites in 9 countries

Spain11 sites

  • Fundacio ACE

    Barcelona, 08028

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Policlínica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Complejo Asistencial Universitario de Salamanca

    Salamaca, Salamanca, 37007

  • Hospital General De Catalunya

    Sant Cugat del Vallès, Barcelona, 8195

  • Hospital Victoria Eugenia

    Seville, 41009

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Hospital Universitario la Fe

    Valencia, 46026

Other trials in Spain

Poland9 sites

  • ProNeuro Centrum Medyczne

    ?ory, 44-240

  • Podlaskie Centrum Psychogeriatrii

    Bia?ystok, 15-756

  • NZOZ Vitamed

    Bydgoszcz, 85-079

  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Katowice, 40-749

  • Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • Senior Sp. Z O.O. Poradnia Psychogeriatryczna

    Sopot, 81-855

  • EUROMEDIS Sp z o o

    Szczecin, 70-111

  • ETG Neuroscience Sp. z o.o.

    Warsaw, 02-777

  • NZOZ WCA

    Wroc?aw, 53-659

Other trials in Poland

France8 sites

  • Groupement Hospitalier Est - Hôpital Neurologique

    Bron, 69677

  • Hopital B Roger Salengro

    Lille, 59037

  • Hôpital de la Timone

    Marseille, 13385

  • Hôpital Lariboisière

    Paris, 75010

  • CHU de Rouen Hopital

    Rouen, 76031

  • Hop Guillaume Et Rene Laennec

    Saint-Herblain, 44800

  • Hôpital Robertsau

    Strasbourg, 67000

  • Gerontopole

    Toulouse, 31059

Other trials in France

United Kingdom6 sites

  • Surrey and Borders NHS Foundation Trust

    Chertsey, KT16 9AU

  • Scottish Brain Sciences

    Edinburgh, EH12 9DQ

  • RE:Cognition Health

    London, W1G 8TA

  • Charing Cross Hospital

    London, W6 8RF

  • Manchester Mental Health and Social Care Trust

    Manchester, M13 9WL

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Italy4 sites

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardy, 27100

  • Umberto I Policlinico di Roma-Università di Roma La Sapienza

    Rome, Lazio, 00185

  • Ospedale Cardinale Panico

    Tricase (LE), Apulia, 73039

Other trials in Italy

Germany3 sites

  • Ambulates Gesundheitszentrum der Charité GmbH

    Berlin, 12200

  • ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

    Berlin, 13125

  • TUM Klinikum rechts der Isar;Ambulanz für neurokognitive Erkrankungen

    München, 81675

Other trials in Germany

Chile2 sites

  • Centro de Investigación Clínica UC-CICUC

    Santiago, 8330034

  • Hospital Clinico Univ de Chile

    Santiago

Other trials in Chile

Denmark2 sites

  • Aarhus Universitetshospital Skejby

    Aarhus N, 8200

  • Rigshospitalet, Hukommelsesklinikken

    Koebenhavn Oe, 2100

Other trials in Denmark

South Korea1 site

  • Inha University Hospital

    Incheon, 22332

Other trials in South Korea

About this study

Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter, Parallel-Group Study to Investigate the Safety, Tolerability, and the Effect of RO7269162 on Amyloid and Non-Amyloid Disease-Related Biomarkers Following Daily Oral Administration in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease

This clinical trial is recruiting people who either are at risk of AD - have build-up of beta-amyloid, but have no clinical symptoms, or with a diagnosis of mild cognitive impairment. People can take part if they have a certain level of plaques (beta-amyloid) in the brain, shown by a positron emission tomography (PET) scan, a medical imaging technique in which tracers are injected to visualize specific pathological processes in the brain. People who take part in this clinical trial (participants) will be given RO7269162 OR placebo for up to about 1 and a half years. The clinical trial team will see them every 3 weeks in the first 3 months and then every 6 weeks until the end of the trial. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have. The total time of participation in the clinical trial will be 90 weeks.

Being tested
RO7269162, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

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

  • RO7269162Drug

    Participants will receive daily doses (one of three dose levels) of RO7269162 for up to 72 weeks.

  • PlaceboDrug

    Participants will receive daily doses of placebo for up to 72 weeks.

Study groups in NCT06402838
Study groupRoleWhat they receive
RO7269162ExperimentalParticipants will receive daily doses of RO7269162 for up to 72 weeks.
Receives: Drug: RO7269162
PlaceboPlacebo comparatorParticipants will receive daily doses of placebo for up to 72 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Incidence of adverse events (AEs)

    Measured: up to week 72

  2. Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan

    Measured: Baseline to Week 72

Secondary outcomes (8)

  1. Change from baseline in Aβ37 in cerebrospinal fluid (CSF)

    Measured: Baseline to Week 72

  2. Change from baseline in Aβ38 in CSF

    Measured: Baseline to Week 72

  3. Change from baseline in Aβ40 in CSF

    Measured: Baseline to Week 72

  4. Change from baseline in Aβ42 in CSF

    Measured: Baseline to Week 72

  5. Change from baseline in Aβ40 in plasma

    Measured: Baseline to Week 72

  6. Change from baseline in Aβ42 in plasma

    Measured: Baseline to Week 72

  7. Plasma concentrations of RO7269162

    Measured: Baseline to Week 72

  8. CSF concentrations of RO7269162

    Measured: Baseline to Week 72

Timeline

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

  1. First posted7 May 2024
  2. Study start2 May 2024
  3. Primary completion19 Nov 2026 (estimated)
  4. Study completion19 Nov 2026 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06402838
Sponsor's protocol ID
BP44745
Status last verified
Aug 2026
First submitted
3 May 2024
Last updated
12 Aug 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 2 study testing RO7269162 in people with Alzheimer's Disease, run by Hoffmann-La Roche at 46 sites in 9 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 6 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Spain, Poland, France, United Kingdom, Italy and 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: up to week 72). The study lists 2 primary outcomes in all. 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 NCT06402838.

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 12 Aug 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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