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)

NCT ID: NCT06402838

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2026-11-10

Brief 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. 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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RO7269162

Participants will receive daily doses of RO7269162 for up to 72 weeks.

Group Type: EXPERIMENTAL

RO7269162

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

RO7269162

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Centro de Investigación Clínica UC-CICUC

Santiago, , Chile

Hospital Clinico Univ de Chile

Santiago, , Chile

Aarhus Universitetshospital Skejby

Aarhus N, , Denmark

Rigshospitalet, Hukommelsesklinikken

Koebenhavn Oe, , Denmark

Groupement Hospitalier Est - Hôpital Neurologique

Bron, , France

Hopital B Roger Salengro

Lille, , France

Hôpital de la Timone

Marseille, , France

Hôpital Lariboisière

Paris, , France

CHU de Rouen Hopital

Rouen, , France

Hop Guillaume Et Rene Laennec

Saint-Herblain, , France

Hôpital Robertsau

Strasbourg, , France

Gerontopole

Toulouse, , France

Ambulates Gesundheitszentrum der Charité GmbH

Berlin, , Germany

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

Berlin, , Germany

TUM Klinikum rechts der Isar;Ambulanz für neurokognitive Erkrankungen

München, , Germany

Ospedale Cardinale Panico

Tricase (LE), Apulia, Italy

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio, Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Lombardy, Italy

ProNeuro Centrum Medyczne

?ory, , Poland

Podlaskie Centrum Psychogeriatrii

Bia?ystok, , Poland

NZOZ Vitamed

Bydgoszcz, , Poland

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

Katowice, , Poland

Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Senior Sp. Z O.O. Poradnia Psychogeriatryczna

Sopot, , Poland

EUROMEDIS Sp z o o

Szczecin, , Poland

ETG Neuroscience Sp. z o.o.

Warsaw, , Poland

NZOZ WCA

Wroc?aw, , Poland

Gachon University Gil Medical Center

Incheon, , South Korea

Inha University Hospital

Incheon, , South Korea

Hospital General De Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Policlínica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, Spain

Complejo Asistencial Universitario de Salamanca

Salamaca, Salamanca, Spain

Fundacio ACE

Barcelona, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Victoria Eugenia

Seville, , Spain

Hospital Virgen del Rocío

Seville, , Spain

Hospital Universitario Dr. Peset

Valencia, , Spain

Hospital Universitario la Fe

Valencia, , Spain

Re:Cognition Health Birmingham

Birmingham, , United Kingdom

Surrey and Borders NHS Foundation Trust

Chertsey, , United Kingdom

Scottish Brain Sciences

Edinburgh, , United Kingdom

RE:Cognition Health

London, , United Kingdom

Charing Cross Hospital

London, , United Kingdom

Manchester Mental Health and Social Care Trust

Manchester, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Countries

Chile; Denmark; France; Germany; Italy; Poland; South Korea; Spain; United Kingdom

Other Identifiers

BP44745

Identifier Type: -

Identifier Source: org_study_id