Start: August 3, 2019
End: July 17, 2020
What Is This Study About?
This Phase I trial will test the safety, tolerability, and pharmacokinetics of increasing doses of the investigational drug RO7126209, which is being developed as a potential treatment for Alzheimer's disease.
Do I Qualify To Participate in This Study?
- No evidence of active or chronic disease on medical history, physical and eye exams, electrocardiogram, and laboratory tests
- Body mass index 18 to 30
- If with a partner who is of childbearing potential, remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of less than 1 percent
- If with a pregnant partner, remain abstinent or use contraceptive measures such as a condom to avoid exposing the embryo
- Refrain from donating sperm
Must NOT have:
- Any disease or condition that could interfere with the study or pose an unacceptable risk to the participant
- History of any significant gastrointestinal, kidney, liver, lung, brain, psychiatric, heart, endocrinological, eye, blood, or allergic disease; metabolic disorder, such as diabetes; or cancer
- History of alcohol or drug abuse in last 5 years
- Positive for hepatitis B, hepatitis C, or HIV
- Significant electrocardiogram abnormalities or abnormalities in laboratory test results
- Any major illness within 1 month of screening exam or fever within 1 week and up to first dose
- Impaired liver function as indicated by screening aspartate aminotransferase or alanine aminotransferase greater than or equal to 1.5 times the upper limit of normal or abnormal total bilirubin unless due to Gilbert's disease
- Hypersensitivity or allergic reactions to relevant drugs, foods, or environmental agents
- Hypersensitivity to biologic agents or any of the study drug ingredients
- History of raised intracerebral pressure or vertebral joint pathology
- Use of prohibited medication or herbal remedies
- Prior administration of gantenerumab
- Vaccination within 2 months prior to Day 1
- Participation in an investigational drug or medical device study within 30 days of screening or within seven times the elimination half-life if known, whichever is longer
- Smoke more than 5 cigarettes daily or are unable or unwilling to not smoke during the in-house period
- Donation or loss of blood over 500 mL within three months prior to Day 1 and donation of blood for the duration of the study until follow-up
- Significant findings on brain magnetic resonance imaging (MRI), including lacunar infarct, territorial infarct or macroscopic hemorrhage, microbleed or area of leptomeningeal hemosiderosis, or deep white matter lesions
- Claustrophobia, presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Reference Study ID Number: BP41192 www.roche.com/about_roche
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Hoffmann-La Roche
Source: ClinicalTrials.gov ID: NCT04023994