Retrieval of Patient Information After Discontinuation (RAPID)

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Alzheimer's Disease

Treatments: Drug: Bapineuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01658722

AAB-001-ALZ-3300

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

169 participants in 1 patient group

Observational

Description:

Long term follow-up

Treatment:

Drug: Bapineuzumab