Alzheimer’s disease · Drug research

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

The registry reports not yet recruiting. This is trial metadata, not an assessment of treatment benefit.

Content updated Oct 28, 2026 · Sources last checked Oct 28, 2026

Who was studied? Read the registry 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.

This record covers only the linked trial population. This registry-based page does not review FDA approval or labeling.

Regulatory context

United States · FDA

FDA approval not reviewed here

Alzheimer’s disease

See FDA labeling for the approved population and indication; this page covers the trial population only.

FDA labeling has not been reviewed for this page. This does not mean the treatment is unapproved.

Approval is specific to the indication and population. It does not establish availability, reimbursement or suitability for an individual.

Clinical trials

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

Enrollment status comes from the registry; check the original record for current details.

Read trial record and posted results

Registry ID: NCT07781657
Phase: Phase 2
Recruitment: Not yet enrolling
Sponsor: Hoffmann-La Roche
Design: Randomized
Comparator: RO7568282 High Dose; RO7568282 Low Dose; Placebo
Planned enrollment: 450
Endpoint: Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)

Study ages: 50 Years to 90 Years. Other eligibility criteria apply; see the full criteria above.

Study countries and territories (including sites that may be closed): United States.

Primary data collection: Nov 1, 2029 (estimated). This is not a results-release date.

No results-posting date in this record.

Evidence 1

Evidence and limitations

Not assessed for clinical effectiveness

registry · Registry metadata is submitted by the sponsor or responsible party and does not independently validate efficacy.

No posted registry results are indicated in this source response. This does not establish that no results exist elsewhere.

Limitations: Outcomes, effect estimates, uncertainty and study quality have not been appraised. Consult original results and publications.

Evidence 1

Sources and verification

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

registry · NCT07781657 · Structured source fields

Source date: Oct 7, 2026 · Checked: Oct 28, 2026

Evidence location: protocolSection: identificationModule, statusModule, conditionsModule, armsInterventionsModule, designModule, outcomesModule, eligibilityModule, contactsLocationsModule, sponsorCollaboratorsModule; hasResults

Status: NOT_YET_RECRUITING. Phase: PHASE2. Conditions: Alzheimer's Disease.

Open original source

Change history

Oct 28, 2026 — Initial registry evidence validated.