NCT00998764 · Phase 3 · TERMINATED
A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
This trial looked at the long-term safety and tolerability of bapineuzumab, an antibody drug given by infusion, in people with Alzheimer's who had finished an earlier study. Participants would stay about four years. It is a Phase 3 extension study, meaning it tracks safety over time, not whether the drug works or is approved.
You may qualify if
- Subject has completed study 3133K1-3001 (Week 78) and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease
- Mini-Mental Status Examination (MMSE) >=10 at screening
- Caregiver able to attend all clinic visits with subject
You're excluded if
- Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
- Any significant brain MRI abnormality.
- Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2016-01-01