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Evaluating RO7269162 for Alzheimer's Disease Risk

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

PHASE2 · Hoffmann-La Roche · NCT06402838

This study is testing a new drug for people at risk of Alzheimer's to see if it can help protect their brain health over about 90 weeks.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment245 (estimated)
Ages60 Years to 85 Years
SexAll
SponsorHoffmann-La Roche (industry)
Drugs / interventionsimmunotherapy
Locations57 sites (Santiago and 56 other locations)
Trial IDNCT06402838 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the safety and biomarker effects of RO7269162 in individuals who are at risk for Alzheimer's Disease (AD) or are in the prodromal stage, characterized by the presence of beta-amyloid plaques without clinical symptoms. Participants will receive either the investigational drug or a placebo over a period of approximately 90 weeks, with regular follow-up visits to monitor their response and any side effects. Eligibility includes individuals with a specific level of amyloid plaques as determined by PET scans, and those who are cognitively unimpaired or diagnosed with mild cognitive impairment. The study aims to gather data on the drug's effects on cognitive function and biomarkers associated with AD.

Who should consider this trial

Good fit: Ideal candidates include cognitively unimpaired individuals or those with mild cognitive impairment due to Alzheimer's Disease who have a positive amyloid PET scan.

Not a fit: Patients who are not at risk for Alzheimer's Disease or do not meet the specific eligibility criteria, such as those with significant cognitive impairment or without amyloid plaques, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for individuals at risk of developing Alzheimer's Disease.

How similar studies have performed: Other studies targeting amyloid plaques in Alzheimer's Disease have shown promise, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

Santiago and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Alzheimer's Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.