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

NCT ID
NCT07781657
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Hoffmann-La Roche
Conditions
Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 450 participants (Estimated).

What is being studied

  • Drug: Placebo
  • Drug: RO7568282

Who may be eligible

Ages
50 Years to 90 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

No study locations are listed in the registry data.

Study details

Start date
October 31, 2026
Primary completion date
November 1, 2029
Completion date
November 1, 2029
First posted
August 24, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07781657
Registry last updated
September 21, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07781657 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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