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RO7568282

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Roche Holding AG|Last Updated: Aug 24, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment450

FDA Designations

No designations recorded

Clinical trial landscape

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

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...

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Recent Changes (Last 90 Days)

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 used for?

RO7568282 is an investigational small molecule being developed by Roche Holding AG (RHHBY) for the treatment of Parkinson's Disease and Alzheimer's Disease. It is currently in Phase 2 clinical development for these neurological conditions.

Who makes RO7568282?

RO7568282 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's effects and safety in patients with early Parkinson's Disease and early symptomatic Alzheimer's Disease.

What phase is RO7568282 in?

RO7568282 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Roche is currently conducting trials to assess its safety and efficacy in Parkinson's Disease and Alzheimer's Disease.

What clinical trials is RO7568282 in?

RO7568282 is being studied in two clinical trials: NCT07781644, a Phase 1 study in early Parkinson's Disease with 474 participants, and NCT07781657, a Phase 2 study in early symptomatic Alzheimer's Disease with 450 participants. Both trials are not yet recruiting and are placebo-controlled, randomized, and double-blind.

Is RO7568282 the same as any other drug?

No alternative names for RO7568282 have been disclosed. It is identified solely by its compound code RO7568282 in clinical trial registrations and by Roche Holding AG.