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)
- Registration Number
- NCT06402838
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 245
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive daily doses of placebo for up to 72 weeks. RO7269162 RO7269162 Participants will receive daily doses of RO7269162 for up to 72 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method CSF concentrations of RO7269162 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 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 plasma Baseline to Week 72 Change from baseline in Aβ42 in plasma Baseline to Week 72 Plasma concentrations of RO7269162 Baseline to Week 72
Trial Locations
- Locations (57)
ProNeuro Centrum Medyczne
🇵🇱?ory, Poland
Podlaskie Centrum Psychogeriatrii
🇵🇱Bia?ystok, Poland
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Victoria Eugenia
🇪🇸Sevilla, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Centro de Investigación Clínica UC-CICUC
🇨🇱Santiago, Chile
Hospital Clinico Univ de Chile
🇨🇱Santiago, Chile
Aalborg Universitetshospital
🇩🇰Aalborg, Denmark
Aarhus Universitetshospital Skejby
🇩🇰Aarhus N, Denmark
Rigshospitalet, Hukommelsesklinikken
🇩🇰Koebenhavn Oe, Denmark
Groupement Hospitalier Est - Hôpital Neurologique
🇫🇷Bron cedex, France
Hopital B Roger Salengro
🇫🇷Lille, France
Hôpital de la Timone
🇫🇷Marseille Cedex 5, France
Hôpital Lariboisière
🇫🇷Paris, France
CHU de Rouen Hopital
🇫🇷Rouen, France
Hop Guillaume Et Rene Laennec
🇫🇷St 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
Studienzentrum Dr. Bischof GmbH
🇩🇪Böblingen, Germany
Universität Leipzig
🇩🇪Leipzig, Germany
Klinikum rechts der Isar der TU München
🇩🇪München, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Umberto I Policlinico di Roma-Università di Roma La Sapienza
🇮🇹Roma, Lazio, Italy
Asst Degli Spedali Civili Di Brescia
🇮🇹Brescia, Lombardia, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
Fondazione Istituto Neurologico Mondino IRCCS
🇮🇹Pavia, Lombardia, Italy
Ospedale Cardinale Panico
🇮🇹Tricase (LE), Puglia, Italy
AO di Perugia - Ospedale S. Maria della Misericordia
🇮🇹Perugia, Umbria, Italy
Ajou University Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
NZOZ Vitamed
🇵🇱Bydgoszcz, Poland
NEURO-CARE Sp. z o.o. Sp. Komandytowa
🇵🇱Katowice, Poland
Szpital Uniwersytecki w Krakowie
🇵🇱Kraków, Poland
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
🇵🇱Sopot, Poland
EUROMEDIS Sp z o o
🇵🇱Szczecin, Poland
ETG Neuroscience Sp. z o.o.
🇵🇱Warszawa, Poland
NZOZ WCA
🇵🇱Wroc?aw, Poland
Hospital General De Catalunya
🇪🇸Sant Cugat del Valles, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸SANtander, Cantabria, 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
🇪🇸Cordoba, 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
Campus for Ageing & Vitality
🇬🇧Newcastle, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom