Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07781657

Study to Test Effects and Safety of RO7568282 in 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).

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RO7568282

Drug

RO7568282 will be administered as specified in the protocol.

Placebo

Drug

RO7568282 matching placebo will be administered as specified in the protocol.

Primary outcomes

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

    Time frame: From baseline up to Week 72

Secondary outcomes

  1. 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

  2. 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

  3. Incidence of Adverse Events (AEs)

    Time frame: Up to approximately Week 76

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

    Time frame: From baseline up to Week 76

  5. Plasma Concentrations of RO7568282 and its Metabolite[s]

    Time frame: Up to approximately Week 76

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: TARBELA-AD

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.