Retrieval of Patient Information After Discontinuation

NCT ID: NCT01658722

Last Updated: 2015-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Long term follow-up

Bapineuzumab

Intervention Type DRUG

Interventions

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Bapineuzumab

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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AAB-001-ALZ-3300

Identifier Type: -

Identifier Source: org_study_id

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