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RO7568282

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Roche Holding AG|Trials Updated: Oct 7, 2026

RO7568282 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Aug 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment924

FDA Designations

No designations recorded

RO7568282 clinical trials

RO7568282 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT07781657Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's DiseaseAlzheimer's Disease
NOT YET_RECRUITING450 Analytics
PHASE2NOT YET_RECRUITING
Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
From baseline up to Week 72
Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score
Up to at least Week 104

Secondary Endpoints

Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)
From baseline up to Week 72
Change From Baseline Through Week 72 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Total Score and Instrumental Score
From baseline up to Week 72
Incidence of Adverse Events (AEs)
Up to approximately Week 76
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO7568282 High DoseEXPERIMENTALParticipants will receive high dose of RO7568282.
RO7568282 Low DoseEXPERIMENTALParticipants will receive low dose of RO7568282.
PlaceboPLACEBO_COMPARATORParticipants will receive RO7568282 matching placebo.

Interventions

NameTypeDescription
RO7568282DRUGRO7568282 will be administered as specified in the protocol.
PlaceboDRUGRO7568282 matching placebo will be administered as specified in the protocol.
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Eligibility Criteria

Age Range50 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Evidence of AD pathological process, as confirmed by either amyloid positron emission tomography (PET) scan or cerebrospinal fluid (CSF) * Mild cognitive impairment (MCI) or mild dementia due to AD * Able to swallow whole capsules * Body mass index (BMI) within the range of 18...

Countries:United States
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Recent Changes (Last 90 Days)

LOWOct 7, 2026NCT07781657lastUpdatePostDate: changed
LOWOct 7, 2026NCT07781657lastUpdatePostDate: changed
LOWSep 21, 2026NCT07781644lastUpdatePostDate: changed
LOWSep 21, 2026NCT07781657lastUpdatePostDate: changed
LOWSep 21, 2026NCT07781644lastUpdatePostDate: changed
LOWSep 21, 2026NCT07781657lastUpdatePostDate: changed
LOWAug 24, 2026NCT07781644NEW_TRIAL: changed
LOWAug 24, 2026NCT07781657NEW_TRIAL: changed
LOWAug 24, 2026NCT07781644NEW_TRIAL: changed
LOWAug 24, 2026NCT07781657NEW_TRIAL: changed

Frequently asked questions about RO7568282

What is RO7568282?

RO7568282 is an investigational small molecule being developed by Roche Holding AG for neurological conditions. It is being studied in Alzheimer's disease and Parkinson's disease. It has not been approved by the FDA and remains in clinical development.

What is RO7568282 used for in Alzheimer's disease?

RO7568282 is being studied as a treatment for early symptomatic Alzheimer's disease. A Phase 2 trial, NCT07781657, is evaluating its effects and safety in adults aged 50 and older in the United States. The study is randomized, double-blind, and placebo-controlled.

What is RO7568282 used for in Parkinson's disease?

RO7568282 is also being investigated for early Parkinson's disease. A Phase 1 trial, NCT07781644, is testing its effects and safety in adults aged 40 and older. That study is not yet recruiting.

Who makes RO7568282?

RO7568282 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the drug in Alzheimer's disease and Parkinson's disease.

What phase is RO7568282 in?

RO7568282 is in Phase 2 development. The lead program is a Phase 2 trial in early symptomatic Alzheimer's disease, while the Parkinson's disease program is in Phase 1. The drug is investigational and has not been approved by the FDA.

What clinical trials is RO7568282 in?

RO7568282 is being evaluated in two registered trials. NCT07781657 is a Phase 2 study in early symptomatic Alzheimer's disease with 450 planned participants. NCT07781644 is a Phase 1 study in early Parkinson's disease with 474 planned participants. Both are not yet recruiting.