Retrieval of Patient Information After Discontinuation

Alzheimer's Disease Clinical Trial

— RAPID  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01658722
• Other study ID #: AAB-001-ALZ-3300
• Status: Terminated
• Phase: N/A
• First received: March 12, 2012
• Last updated: August 31, 2015
• Start date: December 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 169
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Bapineuzumab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
JANSSEN Alzheimer Immunotherapy Research & Development, LLC	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dependence Scale	Caregiver's assessment of a patient's need for assistance	4 years	No