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)

May 15, 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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • 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 Locations

  • Chile
      • Santiago, Chile, 8330034
        • Centro de Investigacion Clinica 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 Rocío
      • 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
        • Policlinica 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

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
Intervention / Treatment
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

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

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

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

Hoffmann-La Roche

Investigators

  • 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)

May 2, 2024

Primary Completion (Estimated)

November 19, 2026

Study Completion (Estimated)

November 19, 2026

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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