We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 14 for:    bapineuzumab

Retrieval of Patient Information After Discontinuation (RAPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01658722
Recruitment Status : Terminated
First Posted : August 7, 2012
Last Update Posted : September 2, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
More Information

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