A study to evaluate the safety and long-term biomarker effects of RO7269162 in participants at risk for or at the prodromal stage of Alzheimer’s Disease (AD)

Trial details

Who runs it

F. Hoffmann-La Roche AG

Trial code

EU 2023-506183-13-00

Record updated

2026. július 3.

Original description

1. To investigate the safety and tolerability of daily oral dosing of RO7269162 and to assess the effect of daily oral dosing of RO7269162 on brain amyloid accumulationRead full original descriptionShow less

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

1. To investigate the safety and tolerability of daily oral dosing of RO7269162 and to assess the effect of daily oral dosing of RO7269162 on brain amyloid accumulation

Inclusion: Body Mass Index (BMI) between 18 to 35 kg/m2 inclusive, at screening; Participants must be either cognitively unimpaired or with a diagnosis of MCI due to AD, according to the NIA – AA workgroups on diagnostic guidelines for AD, and/or according to the updated 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 first IMP intake.

Exclusion: 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 first IMP intake, and/or any other investigational treatment within five half-lives or 16 weeks prior to screening, whichever is longer; 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 activate inflammatory bowel disease.

EU CTIS 2023-506183-13-00