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Clinical Trials in the UK / NCT06402838
Active, not recruiting Phase 2

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 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2024-05-02
Last updated
2026-08-12

Condition(s) studied

Alzheimer's Disease

Investigational drug(s) / intervention(s)

RO7269162Placebo

RO7269162: 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.

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (46)

FacilityCityRegionStatus
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
Umberto I Policlinico di Roma-Università di Roma La Sapienza Rome Lazio
IRCCS Ospedale San Raffaele Milan Lombardy
Fondazione Istituto Neurologico Mondino IRCCS Pavia Lombardy
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
Inha University Hospital Incheon South Korea
Hospital General De Catalunya Sant Cugat del Vallès Barcelona
Policlínica Guipuzcoa Donostia / San Sebastian Guipuzcoa
Hospital Quiron de Madrid Pozuelo de Alarcón Madrid
Complejo Asistencial Universitario de Salamanca Salamaca Salamanca
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

+ 6 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06402838 on ClinicalTrials.gov ↗ ← All trials in the UK