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)

NCT06402838 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BP44745
• Study Type: interventional
• Target: 256
• Locations: 9 countries
• Sites: 46

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs)

  up to week 72

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

  Baseline to Week 72

Secondary Outcomes (8)

• Change from baseline in Aβ37 in cerebrospinal fluid (CSF)

  Baseline to Week 72

• Change from baseline in Aβ38 in CSF

  Baseline to Week 72

• Change from baseline in Aβ40 in CSF

  Baseline to Week 72

• Change from baseline in Aβ42 in CSF

  Baseline to Week 72

• Change from baseline in Aβ40 in plasma

  Baseline to Week 72

Other Outcomes (1)

• Change from baseline in p-tau 217 in plasma

  Baseline to Week 72

Study Arms (2)

RO7269162

EXPERIMENTAL

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

Drug: RO7269162

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RO7269162 DRUG

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

RO7269162

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (46)

Centro de Investigación Clínica UC-CICUC

Santiago, 8330034, Chile

Location

Hospital Clinico Univ de Chile

Santiago, Chile

Location

Aarhus Universitetshospital Skejby

Aarhus N, 8200, Denmark

Location

Rigshospitalet, Hukommelsesklinikken

Koebenhavn Oe, 2100, Denmark

Location

Groupement Hospitalier Est - Hôpital Neurologique

Bron, 69677, France

Location

Hopital B Roger Salengro

Lille, 59037, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

CHU de Rouen Hopital

Rouen, 76031, France

Location

Hop Guillaume Et Rene Laennec

Saint-Herblain, 44800, France

Location

Hôpital Robertsau

Strasbourg, 67000, France

Location

Gerontopole

Toulouse, 31059, France

Location

Ambulates Gesundheitszentrum der Charité GmbH

Berlin, 12200, Germany

Location

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

Berlin, 13125, Germany

Location

TUM Klinikum rechts der Isar;Ambulanz für neurokognitive Erkrankungen

München, 81675, Germany

Location

Ospedale Cardinale Panico

Tricase (LE), Apulia, 73039, Italy

Location

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio, 00185, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Lombardy, 27100, Italy

Location

ProNeuro Centrum Medyczne

?ory, 44-240, Poland

Location

Podlaskie Centrum Psychogeriatrii

Bia?ystok, 15-756, Poland

Location

NZOZ Vitamed

Bydgoszcz, 85-079, Poland

Location

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

Katowice, 40-749, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

Location

Senior Sp. Z O.O. Poradnia Psychogeriatryczna

Sopot, 81-855, Poland

Location

EUROMEDIS Sp z o o

Szczecin, 70-111, Poland

Location

ETG Neuroscience Sp. z o.o.

Warsaw, 02-777, Poland

Location

NZOZ WCA

Wroc?aw, 53-659, Poland

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Hospital General De Catalunya

Sant Cugat del Vallès, Barcelona, 8195, Spain

Location

Policlínica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamaca, Salamanca, 37007, Spain

Location

Fundacio ACE

Barcelona, 08028, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Victoria Eugenia

Seville, 41009, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

Hospital Universitario la Fe

Valencia, 46026, Spain

Location

Surrey and Borders NHS Foundation Trust

Chertsey, KT16 9AU, United Kingdom

Location

Scottish Brain Sciences

Edinburgh, EH12 9DQ, United Kingdom

Location

RE:Cognition Health

London, W1G 8TA, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Manchester Mental Health and Social Care Trust

Manchester, M13 9WL, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: May 2, 2024
• Primary Completion (Estimated): November 19, 2026
• Study Completion (Estimated): November 19, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (8); CL (2); DE (3); DK (2); KR (1); GB (6); PL (9); ES (11); IT (4)