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

Neurodegenerative Disorder
Alzheimer's Disease (AD)

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 2

Trial Identifier NCT07781657, BP46554, 2026-526158-14-00

Condition Alzheimer's Disease

Official 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

Study Summary

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

Eligibility Criteria

Gender

All

Age

≥50 Years & ≤ 90 Years

Healthy Volunteers

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.

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com