Recent Updates
Recently added Catalysts

RO7269162

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment256

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

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

Frequently asked questions about RO7269162

What is RO7269162 used for?

RO7269162 is an investigational small molecule being developed for Alzheimer's Disease. It is currently being studied in participants at risk for or at the prodromal stage of Alzheimer's Disease, meaning those who may be in the early or pre-symptomatic phases of the condition.

Who makes RO7269162?

RO7269162 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 2 clinical trial to evaluate the safety and biomarker effects of this investigational drug in Alzheimer's Disease.

What phase is RO7269162 in?

RO7269162 is in Phase 2 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in Alzheimer's Disease.

What clinical trials is RO7269162 in?

RO7269162 is being studied in a Phase 2 trial with the identifier NCT06402838. This trial is active but not recruiting participants and has an enrollment of 256. It is a randomized, double-blind, placebo-controlled study evaluating safety and biomarker effects in Alzheimer's Disease.

Is RO7269162 the same as another drug?

RO7269162 is the primary name for this investigational drug. No alternative names have been associated with it in the available information, so it is not known to be the same as any other drug.