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Retrieval of Patient Information After Discontinuation (RAPID)

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01658722
First received: March 12, 2012
Last updated: August 24, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Alzheimer's Disease
 Drug: Bapineuzumab

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Primary Outcome Measures:
  • Dependence Scale [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Caregiver's assessment of a patient's need for assistance


Enrollment: 169
Study Start Date: December 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational
Long term follow-up
 Drug: Bapineuzumab

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01658722     History of Changes
Other Study ID Numbers: AAB-001-ALZ-3300
Study First Received: March 12, 2012
Last Updated: August 24, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013