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RO7269162

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Roche Holding AG|Trials Updated: Aug 12, 2026

RO7269162 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment256

FDA Designations

No designations recorded

RO7269162 clinical trials

RO7269162 · 1 trial · 1 indication

Phase 2 1
NCT06402838A 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)Alzheimer's Disease
ACTIVE NOT_RECRUITING256 Analytics
PHASE2ACTIVE NOT_RECRUITING
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)
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AEs)
up to week 72
Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan
Baseline to Week 72

Secondary Endpoints

Change from baseline in Aβ37 in cerebrospinal fluid (CSF)
Baseline to Week 72
Change from baseline in Aβ38 in CSF
Baseline to Week 72
Change from baseline in Aβ40 in CSF
Baseline to Week 72
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO7269162EXPERIMENTALParticipants will receive daily doses of RO7269162 for up to 72 weeks.
PlaceboPLACEBO_COMPARATORParticipants will receive daily doses of placebo for up to 72 weeks.

Interventions

NameTypeDescription
RO7269162DRUGParticipants will receive daily doses (one of three dose levels) of RO7269162 for up to 72 weeks.
PlaceboDRUGParticipants will receive daily doses of placebo for up to 72 weeks.
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Eligibility Criteria

Age Range60 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites46

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 Deme...

Countries:ChileDenmarkFranceGermanyItalyPolandSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 12, 2026NCT06402838lastUpdatePostDate: changed
LOWAug 12, 2026NCT06402838lastUpdatePostDate: changed

Frequently asked questions about RO7269162

What is RO7269162?

RO7269162 is an investigational small molecule being developed by Roche Holding AG for Alzheimer's disease. It is in Phase 2 clinical development and is being studied in people at risk for or at the prodromal stage of Alzheimer's disease. It has not been approved by the FDA.

What is RO7269162 used for in Alzheimer's disease?

RO7269162 is being studied for Alzheimer's disease in individuals who are at risk for or at the prodromal stage of the condition. The Phase 2 trial evaluates its safety and biomarker effects. It is investigational and not approved for any use.

Who is developing RO7269162?

RO7269162 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the ongoing Phase 2 clinical trial for this asset.

What phase is RO7269162 in?

RO7269162 is in Phase 2 clinical development. One Phase 2 trial is active and not recruiting, with a planned enrollment of 256 participants. The drug is investigational and has not received FDA approval.

What clinical trials is RO7269162 in?

RO7269162 is being evaluated in the Phase 2 trial NCT06402838, titled 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. The trial is active but not recruiting, with 256 participants across multiple countries.