NCT07781657Not yet recruitingPhase 2
Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease
A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early Symptomatic Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 1 Nov 2029
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Alzheimer disease
- NCT number
- NCT07781657
- EU CT number
- 2026-526158-14-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 450
- From 31 Oct 2026 to the primary completion date, 1 Nov 2029
- 36 sites in 8 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.
Other illness
- Any evidence of a condition other than AD that may affect cognition
- Participants must not have unstable or clinically significant cardiovascular disease within the last year, chronic uncontrolled hypertension, or clinically significant electrocardiogram (ECG) abnormalities
- History or presence of clinically significant cerebrovascular disease
Other
- Clinically significant cerebral abnormalities on magnetic resonance imaging (MRI)
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Who the study is looking for
- Evidence of AD pathological process, as confirmed by either amyloid positron emission tomography (PET) scan or cerebrospinal fluid (CSF)
- Mild cognitive impairment (MCI) or mild dementia due to AD
- Able to swallow whole capsules
- Body mass index (BMI) within the range of 18-34 kilograms per square metre (kg/m²) (at screening)
- Availability of an appropriate study partner
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Not yet recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Not yet recruiting |
| Algemeen Ziekenhuis Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Not yet recruiting |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Not yet recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Not yet recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Not yet recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Not yet recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
| Region Nordjylland Coordinator of this site? Confirm its status | Aalborg | Denmark | Not yet recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Not yet recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Not yet recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Mercy University Hospital Coordinator of this site? Confirm its status | Cork | Ireland | Not yet recruiting |
| Tallaght University Hospital Coordinator of this site? Confirm its status | Dublin 24 | Ireland | Not yet recruiting |
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin 4 | Ireland | Not yet recruiting |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Not yet recruiting |
| Fondazione Istituto G. Giglio Di Cafalu Coordinator of this site? Confirm its status | Cefalu' | Italy | Not yet recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Fondazione Santa Lucia Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Centrum Medyczne Neuromed Sp. z.o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Not yet recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych Im. Ksiedza Henryka Kardynala Gulbinowicza Osrodek Alzheimerowski Sp. z o.o. Coordinator of this site? Confirm its status | Scinawa | Poland | Not yet recruiting |
| EUROMEDIS Sp z o o Coordinator of this site? Confirm its status | Szczecin | Poland | Not yet recruiting |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| NZOZ Wroclawskie Centrum Alzheimerowskie Coordinator of this site? Confirm its status | Wroclaw | Poland | Not yet recruiting |
| Basil Clinical Coordinator of this site? Confirm its status | Laurelton | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.