Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease (TARBELA-AD)

August 20, 2026 updated by: Hoffmann-La Roche

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

This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RO7568282 High Dose
Participants will receive high dose of RO7568282.
Drug: RO7568282
RO7568282 will be administered as specified in the protocol.
Experimental: RO7568282 Low Dose
Participants will receive low dose of RO7568282.
Drug: RO7568282
RO7568282 will be administered as specified in the protocol.
Placebo Comparator: Placebo
Participants will receive RO7568282 matching placebo.
Drug: Placebo
RO7568282 matching placebo will be administered as specified in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Time Frame: From baseline up to Week 72
From baseline up to Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: From baseline up to Week 72
From baseline up to Week 72
Incidence of Adverse Events (AEs)
Time Frame: Up to approximately Week 76
Up to approximately Week 76
Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)
Time Frame: From baseline up to Week 76
From baseline up to Week 76
Plasma Concentrations of RO7568282 and its Metabolite[s]
Time Frame: Up to approximately Week 76
Up to approximately Week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

August 20, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 24, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP46554
  • 2026-526158-14-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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