Alzheimer's Disease
Conditions
Brief summary
A Phase 3b, Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies ELN115727-301 and 302 but did not Enroll in Study ELN115727-351.
Interventions
DRUGBapineuzumab
Sponsors
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed, dated, and written informed consent obtained from the subject and/or the subject's legally acceptable representative (LAR, if applicable) in accordance with local regulations. 2. Signed, dated, and written informed consent, obtained from the subject's caregiver in accordance with local regulations. 3. Subject must have participated in the Study 301, 302, or 351 and have received at least 1 dose of study treatment (bapineuzumab or placebo). 4. Subject must have been off treatment for at least 12 months prior to Visit 1. 5. Subjects must have a primary caregiver for the duration of the study. 6. Subject's caregiver must have the ability to assess the subject and answer questions over the phone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dependence Scale | 4 years | Caregiver's assessment of a patient's need for assistance |
Outcome results
None listed