Trial record 12 of 14 for:
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.
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 May 23, 2013
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders