NCT01658722

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2012

Enrollment Period

8 months

First QC Date

March 12, 2012

Last Update Submit

August 31, 2015

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Dependence Scale

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

    4 years

Study Arms (1)

Observational

Long term follow-up

Drug: Bapineuzumab

Interventions

BapineuzumabDRUG
Observational

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Interventions

bapineuzumab

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2012

First Posted

August 7, 2012

Study Start

December 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

September 2, 2015

Record last verified: 2012-08