Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro de Investigación Clínica UC-CICUC
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Hospital Clinico Univ de Chile
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Ambulates Gesundheitszentrum der Charité GmbH
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
TUM Klinikum rechts der Isar;Ambulanz für neurokognitive Erkrankungen
Coordinator of this site? Confirm its status
MünchenGermanyUnknown status
Aarhus Universitetshospital Skejby
Coordinator of this site? Confirm its status
Aarhus NDenmarkUnknown status
Rigshospitalet, Hukommelsesklinikken
Coordinator of this site? Confirm its status
Koebenhavn OeDenmarkUnknown status
Fundació ACE
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital Universitario Reina Sofia
Coordinator of this site? Confirm its status
CórdobaSpainUnknown status
Policlínica Guipuzcoa
Coordinator of this site? Confirm its status
Donostia / San SebastianSpainUnknown status
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Quiron de Madrid
Coordinator of this site? Confirm its status
Pozuelo de AlarcónSpainUnknown status
Complejo Asistencial Universitario de Salamanca
Coordinator of this site? Confirm its status
SalamacaSpainUnknown status
Hospital General De Catalunya
Coordinator of this site? Confirm its status
Sant Cugat del VallèsSpainUnknown status
Hospital Virgen Del Rocio
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Hospital Victoria Eugenia
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Hospital Universitario la Fe
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Hospital Universitario Dr. Peset
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Groupement Hospitalier Est - Hôpital Neurologique
Coordinator of this site? Confirm its status
BronFranceUnknown status
Hopital B Roger Salengro
Coordinator of this site? Confirm its status
LilleFranceUnknown status
Hopital de la Timone
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
Hôpital Lariboisière
Coordinator of this site? Confirm its status
ParisFranceUnknown status
CHU de Rouen Hopital
Coordinator of this site? Confirm its status
RouenFranceUnknown status
Hop Guillaume Et Rene Laennec
Coordinator of this site? Confirm its status
Saint-HerblainFranceUnknown status
Hôpital Robertsau
Coordinator of this site? Confirm its status
StrasbourgFranceUnknown status
Gerontopole
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
Surrey and Borders NHS Foundation Trust
Coordinator of this site? Confirm its status
ChertseyUnited KingdomUnknown status
Scottish Brain Sciences
Coordinator of this site? Confirm its status
EdinburghUnited KingdomUnknown status
Charing Cross Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
RE:Cognition Health
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Manchester Mental Health and Social Care Trust
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Southampton General Hospital
Coordinator of this site? Confirm its status
SouthamptonUnited KingdomUnknown status
IRCCS Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Fondazione Istituto Neurologico Mondino IRCCS
Coordinator of this site? Confirm its status
PaviaItalyUnknown status
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Coordinator of this site? Confirm its status
RomeItalyUnknown status
Ospedale Cardinale Panico
Coordinator of this site? Confirm its status
Tricase (LE)ItalyUnknown status
Inha University Hospital
Coordinator of this site? Confirm its status
IncheonSouth KoreaUnknown status
Podlaskie Centrum Psychogeriatrii
Coordinator of this site? Confirm its status
Bia?ystokPolandUnknown status
NZOZ Vitamed
Coordinator of this site? Confirm its status
BydgoszczPolandUnknown status
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Coordinator of this site? Confirm its status
KatowicePolandUnknown status
Szpital Uniwersytecki w Krakowie
Coordinator of this site? Confirm its status
KrakowPolandUnknown status
ProNeuro Centrum Medyczne
Coordinator of this site? Confirm its status
?oryPolandUnknown status
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
Coordinator of this site? Confirm its status
SopotPolandUnknown status
EUROMEDIS Sp z o o
Coordinator of this site? Confirm its status
SzczecinPolandUnknown status
ETG Neuroscience Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandUnknown status
NZOZ WCA
Coordinator of this site? Confirm its status
Wroc?awPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.