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Retrieval of Patient Information After Discontinuation (RAPID)

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ClinicalTrials.gov Identifier: NCT01658722
Recruitment Status : Terminated
First Posted : August 7, 2012
Last Update Posted : September 2, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC

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.

Condition or disease Intervention/treatment
Alzheimer's Disease Drug: Bapineuzumab

Study Type : Observational
Actual Enrollment : 169 participants
Time Perspective: Prospective
Official Title: 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 ELN15727-301 and 302 But Did Not Enroll in Study ELN115727-351
Study Start Date : December 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Observational
Long term follow-up
Drug: Bapineuzumab



Primary Outcome Measures :
  1. Dependence Scale [ Time Frame: 4 years ]
    Caregiver's assessment of a patient's need for assistance



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with Alzheimer's disease who discontinued treatment in bapineuzumab Phase 3 clinical studies (ELN115727-301/302/351) or who completed studies ELN115727-301 or 302 but did not enroll in study ELN115727-351
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.

Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01658722     History of Changes
Other Study ID Numbers: AAB-001-ALZ-3300
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2012

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders