Last updated 23 days ago
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)
245 patients around the world
Available in Spain, Chile
Hoffmann-La Roche
1Research sites
245Patients around the world
This study is for people with
Alzheimer disease
Requirements for the patient
To 85 Years
All Gender
Medical requirements
- 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.
Sites
Centro de Investigaciones Clínicas UC - CICUC
Recruiting
SponsorHoffmann-La Roche
Conditions
Alzheimer disease
Requirements
To 85 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06402838
