TARBELA-AD

Not yet recruitingPhase 2

Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease

A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early Symptomatic Alzheimer's Disease

Lead sponsor

Hoffmann-La Roche

Asset

RO7568282

Listed sites

Recruiting sites

Enrollment

450

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET/CSF)

Primary endpoint

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

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

Ctis2026-526158-14-00

Org study IDBP46554

NCT IDNCT07781657

Timeline

Milestones

Study first posted2026-08-24actual

Last update posted2026-10-07actual

Study start2026-10-31estimated

Primary completion2029-11-01estimated

Study completion2029-11-01estimated

Assets

Drug assets

RO7568282

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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 18-34 kilograms per square metre (kg/m²) (at screening)

•Availability of an appropriate study partner

Exclusion criteria

•Any evidence of a condition other than AD that may affect cognition

•Participants must not have unstable or clinically significant cardiovascular disease within the last year, chronic uncontrolled hypertension, or clinically significant electrocardiogram (ECG) abnormalities

•History or presence of clinically significant cerebrovascular disease

•Clinically significant cerebral abnormalities on magnetic resonance imaging (MRI)

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Endpoints (6)

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

Global cognition

Other (unclassified)

Function / daily living

Safety / tolerability / PK

Global cognition

2 endpoints

Primary/protocol endpoint

Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)

Time frame:From baseline up to Week 72

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)

Time frame:From baseline up to Week 72

ADAS-Cog

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change From Baseline Through Week 72 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Total Score and Instrumental Score

Time frame:From baseline up to Week 72

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Incidence of Adverse Events (AEs)

Time frame:Up to approximately Week 76

event count, event

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)

Time frame:From baseline up to Week 76

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Plasma Concentrations of RO7568282 and its Metabolite[s]

Time frame:Up to approximately Week 76

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.