Retrieval of Patient Information After Discontinuation (RAPID)
This study has been terminated.
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
First received: March 12, 2012
Last updated: August 24, 2012
Last verified: August 2012
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.
||Time Perspective: Prospective
||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
Primary Outcome Measures:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
Long term follow-up
|Ages Eligible for Study:
||55 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- 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.
- Signed, dated, and written informed consent, obtained from the subject's caregiver in accordance with local regulations.
- Subject must have participated in the Study 301, 302, or 351 and have received at least 1 dose of study treatment (bapineuzumab or placebo).
- Subject must have been off treatment for at least 12 months prior to Visit 1.
- Subjects must have a primary caregiver for the duration of the study.
- Subject's caregiver must have the ability to assess the subject and answer questions over the phone.
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, see Learn About Clinical Studies.
No Contacts or Locations Provided
No publications provided
||JANSSEN Alzheimer Immunotherapy Research & Development, LLC
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 12, 2012
||August 24, 2012
||United States: Food and Drug Administration
Canada: Health Canada
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Nervous System Diseases