Active 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

Lead sponsor

Hoffmann-La Roche

Asset

RO7269162

Listed sites

Recruiting sites

Enrollment

256

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MCI due to AD•Amyloid biomarker required (PET)

Primary endpoints

•Adverse events (AEs)•Brain amyloid load

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDBP44745

NCT IDNCT06402838

Timeline

Milestones

Study start2024-05-02actual

Study first posted2024-05-07actual

Last update posted2026-05-18actual

Primary completion2026-11-19estimated

Study completion2026-11-19estimated

Assets

Drug assets

RO7269162

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers

Tau biomarkers

Fluid / digital biomarkers

Safety / tolerability / PK

Other (unclassified)

Amyloid biomarkers

7 endpoints

Primary/protocol endpoint

Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Aβ37 in cerebrospinal fluid (CSF)

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Aβ38 in CSF

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Aβ40 in CSF

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Aβ42 in CSF

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Aβ40 in plasma

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Aβ42 in plasma

Time frame:Baseline to Week 72

change from baseline, improvement

Tau biomarkers

1 endpoint

Other/protocol endpoint

Change from baseline in p-tau 217 in plasma

Time frame:Baseline to Week 72

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

CSF concentrations of RO7269162

Time frame:Baseline to Week 72

concentration, descriptive

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Incidence of adverse events (AEs)

Time frame:up to week 72

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Plasma concentrations of RO7269162

Time frame:Baseline to Week 72

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.