Retrieval of Patient Information After Discontinuation

JANSSEN Alzheimer Immunotherapy Research & Development, LLC169 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

169

Conditions

Alzheimer's Disease

Interventions

BapineuzumabDRUG

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Dependence Scale

Caregiver's assessment of a patient's need for assistance

Time frame: 4 years

Data from ClinicalTrials.gov

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