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)

August 11, 2026 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
256

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Chile
      • Santiago, Chile, 8330034
        • Centro de Investigación Clínica UC-CICUC
      • Santiago, Chile
        • Hospital Clinico Univ de Chile
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital Skejby
      • Koebenhavn Oe, Denmark, 2100
        • Rigshospitalet, Hukommelsesklinikken
  • France
      • Bron, France, 69677
        • Groupement Hospitalier Est - Hôpital Neurologique
      • Lille, France, 59037
        • Hopital B Roger Salengro
      • Marseille, France, 13385
        • Hôpital de la Timone
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Rouen, France, 76031
        • CHU de Rouen Hopital
      • Saint-Herblain, France, 44800
        • Hop Guillaume Et Rene Laennec
      • Strasbourg, France, 67000
        • Hôpital Robertsau
      • Toulouse, France, 31059
        • Gerontopole
  • Germany
      • Berlin, Germany, 13125
        • ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
      • Berlin, Germany, 12200
        • Ambulates Gesundheitszentrum der Charité GmbH
      • München, Germany, 81675
        • TUM Klinikum rechts der Isar;Ambulanz für neurokognitive Erkrankungen
  • Italy
    • Apulia
      • Tricase (LE), Apulia, Italy, 73039
        • Ospedale Cardinale Panico
    • Lazio
      • Rome, Lazio, Italy, 00185
        • Umberto I Policlinico di Roma-Università di Roma La Sapienza
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Pavia, Lombardy, Italy, 27100
        • Fondazione Istituto Neurologico Mondino IRCCS
  • Poland
      • ?ory, Poland, 44-240
        • ProNeuro Centrum Medyczne
      • Bia?ystok, Poland, 15-756
        • Podlaskie Centrum Psychogeriatrii
      • Bydgoszcz, Poland, 85-079
        • NZOZ Vitamed
      • Katowice, Poland, 40-749
        • NEURO-CARE Sp. z o.o. Sp. Komandytowa
      • Krakow, Poland, 30-688
        • Szpital Uniwersytecki w Krakowie
      • Sopot, Poland, 81-855
        • Senior Sp. Z O.O. Poradnia Psychogeriatryczna
      • Szczecin, Poland, 70-111
        • EUROMEDIS Sp z o o
      • Warsaw, Poland, 02-777
        • ETG Neuroscience Sp. z o.o.
      • Wroc?aw, Poland, 53-659
        • NZOZ WCA
  • South Korea
      • Incheon, South Korea, 22332
        • Inha University Hospital
  • Spain
      • Barcelona, Spain, 08028
        • Fundació ACE
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Seville, Spain, 41013
        • Hospital Virgen Del Rocio
      • Seville, Spain, 41009
        • Hospital Victoria Eugenia
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe
    • Barcelona
      • Sant Cugat del Vallès, Barcelona, Spain, 8195
        • Hospital General De Catalunya
    • Guipuzcoa
      • Donostia / San Sebastian, Guipuzcoa, Spain, 20014
        • Policlínica Guipuzcoa
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Quiron de Madrid
    • Salamanca
      • Salamaca, Salamanca, Spain, 37007
        • Complejo Asistencial Universitario de Salamanca
  • United Kingdom
      • Chertsey, United Kingdom, KT16 9AU
        • Surrey and Borders NHS Foundation Trust
      • Edinburgh, United Kingdom, EH12 9DQ
        • Scottish Brain Sciences
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, United Kingdom, W1G 8TA
        • Re:Cognition Health
      • Manchester, United Kingdom, M13 9WL
        • Manchester Mental Health and Social Care Trust
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RO7269162
Participants will receive daily doses of RO7269162 for up to 72 weeks.
Drug: RO7269162
Participants will receive daily doses (one of three dose levels) of RO7269162 for up to 72 weeks.
Placebo Comparator: Placebo
Participants will receive daily doses of placebo for up to 72 weeks.
Drug: Placebo
Participants will receive daily doses of placebo for up to 72 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: up to week 72
up to week 72
Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan
Time Frame: Baseline to Week 72
Baseline to Week 72

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in Aβ37 in cerebrospinal fluid (CSF)
Time Frame: Baseline to Week 72
Baseline to Week 72
Change from baseline in Aβ38 in CSF
Time Frame: Baseline to Week 72
Baseline to Week 72
Change from baseline in Aβ40 in CSF
Time Frame: Baseline to Week 72
Baseline to Week 72
Change from baseline in Aβ42 in CSF
Time Frame: Baseline to Week 72
Baseline to Week 72
Change from baseline in Aβ40 in plasma
Time Frame: Baseline to Week 72
Baseline to Week 72
Change from baseline in Aβ42 in plasma
Time Frame: Baseline to Week 72
Baseline to Week 72
Plasma concentrations of RO7269162
Time Frame: Baseline to Week 72
Baseline to Week 72
CSF concentrations of RO7269162
Time Frame: Baseline to Week 72
Baseline to Week 72

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in p-tau 217 in plasma
Time Frame: Baseline to Week 72
Baseline to Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 19, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP44745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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