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

RecruitingPhase 2

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

Who can join

Ages 50 to 90 · All sexes

Full 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.

About the study

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

What is being tested

RO7568282 (drug)
Placebo (drug)

Sponsor: Hoffmann-La Roche · Participants: 450 · Started: Nov 15, 2026

Contact the study team

Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below. · Phone: 888-662-6728

Official record on ClinicalTrials.gov — NCT07781657

Locations in the U.S.

Florida	Alzheimer's Research and Treatment Center, Stuart Alzheimer?s Research and Treatment Center, Wellington Conquest Research, LLC, Winter Park
New York	Basil Clinical, Laurelton

Conditions

Alzheimer's Disease

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.