NCT06402838Active, not recruitingPhase 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)
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 256 (actual)
- First submitted
- 3 May 2024
- Start date
- 2 May 2024
- Primary completion date
- 19 Nov 2026
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Alzheimer disease
- NCT number
- NCT06402838
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 256
- From 2 May 2024 to the primary completion date, 19 Nov 2026
- 46 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Investigación Clínica UC-CICUC Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Hospital Clinico Univ de Chile Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Ambulates Gesundheitszentrum der Charité GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| TUM Klinikum rechts der Isar;Ambulanz für neurokognitive Erkrankungen Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Aarhus Universitetshospital Skejby Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
| Rigshospitalet, Hukommelsesklinikken Coordinator of this site? Confirm its status | Koebenhavn Oe | Denmark | Unknown status |
| Fundació ACE Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Policlínica Guipuzcoa Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Quiron de Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Unknown status |
| Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamaca | Spain | Unknown status |
| Hospital General De Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Unknown status |
| Hospital Virgen Del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Victoria Eugenia Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario Dr. Peset Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Groupement Hospitalier Est - Hôpital Neurologique Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| Hopital B Roger Salengro Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Lariboisière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Rouen Hopital Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Hop Guillaume Et Rene Laennec Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Hôpital Robertsau Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Gerontopole Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Surrey and Borders NHS Foundation Trust Coordinator of this site? Confirm its status | Chertsey | United Kingdom | Unknown status |
| Scottish Brain Sciences Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Charing Cross Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| RE:Cognition Health Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Manchester Mental Health and Social Care Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione Istituto Neurologico Mondino IRCCS Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Umberto I Policlinico di Roma-Università di Roma La Sapienza Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Ospedale Cardinale Panico Coordinator of this site? Confirm its status | Tricase (LE) | Italy | Unknown status |
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Podlaskie Centrum Psychogeriatrii Coordinator of this site? Confirm its status | Bia?ystok | Poland | Unknown status |
| NZOZ Vitamed Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| NEURO-CARE Sp. z o.o. Sp. Komandytowa Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Szpital Uniwersytecki w Krakowie Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| ProNeuro Centrum Medyczne Coordinator of this site? Confirm its status | ?ory | Poland | Unknown status |
| Senior Sp. Z O.O. Poradnia Psychogeriatryczna Coordinator of this site? Confirm its status | Sopot | Poland | Unknown status |
| EUROMEDIS Sp z o o Coordinator of this site? Confirm its status | Szczecin | Poland | Unknown status |
| ETG Neuroscience Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| NZOZ WCA Coordinator of this site? Confirm its status | Wroc?aw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.