RAPID: Retrieval of Patient Information After Discontinuation

• Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01658722
• Collaborator: Pfizer (Industry)
• Enrollment: 169
• Duration (Months): 8

Study Details

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	Phase
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: Dec 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Observational Long term follow-up	Drug: Bapineuzumab

Outcome Measures

Primary Outcome Measures

1. Dependence Scale [4 years]

   Caregiver's assessment of a patient's need for assistance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Pfizer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT01658722
• Other Study ID Numbers: AAB-001-ALZ-3300
• First Posted: Aug 7, 2012
• Last Update Posted: Sep 2, 2015
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Sep 2, 2015