Test of RO7568282 vs placebo in early 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
Run by Hoffmann-La Roche · NCT07781657 · Data updated 2026-11-12
This study tests whether RO7568282 can help people in the early stages of Alzheimer's disease compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 7 sites (Stuart, Florida and 6 other locations) |
| Status | Recruiting |
| Started | November 15, 2026 |
| Main results expected | November 1, 2029 |
| Study ends | November 1, 2029 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07781657 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with early AD confirmed by biomarker evidence, MCI or mild dementia due to AD, able to swallow capsules, BMI 18–34, and with an available study partner.
✕Probably not a fit
Patients with non-AD cognitive conditions, unstable cardiovascular disease, recent stroke or major brain abnormalities may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 interventional trial compares RO7568282 to placebo in adults with early Alzheimer's disease, including mild cognitive impairment or mild dementia due to AD. Participants must show AD pathology on PET or CSF and be able to swallow capsules, with a BMI between 18 and 34 and a study partner available. Key exclusions involve other cognitive-impairing conditions, recent significant cardiovascular disease, stroke, or major brain abnormalities on MRI. The study is led by Hoffmann-La Roche and conducted at sites in Florida.
Why it matters
Potential benefit: If successful, RO7568282 could provide symptom relief or disease progression delay for some patients with early AD.
How similar studies have gone: Previous studies in similar approaches have shown mixed results; this trial explores a novel therapeutic in a defined AD population.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Alzheimer's Research and Treatment Center
Stuart, Florida, United States Recruiting -
Alzheimer?s Research and Treatment Center
Wellington, Florida, United States Recruiting -
Conquest Research, LLC
Winter Park, Florida, United States Recruiting -
Basil Clinical
Laurelton, New York, United States Recruiting -
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia Recruiting -
Royal Melbourne Hospital
Parkville, Victoria, Australia Recruiting
Show 1 more location
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Groupement Hospitalier Est - Hôpital Neurologique
Bron, France Recruiting
Study contacts
- Study coordinator: Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.