Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients

Alzheimer Disease Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy And Safety Trial Of Bapineuzumab In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E ε4 Carriers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00676143
• Other study ID #: 3133K1-3001
• Secondary ID: B2521002
• Status: Terminated
• Phase: Phase 3
• First received: May 2, 2008
• Last updated: December 20, 2012
• Start date: May 2008
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Other known NCT identifiers

• NCT00909675

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1099
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 88 Years

Eligibility

Inclusion Criteria:

• Diagnosis of probable AD, with MMSE score of 16-26, and brain MRI consistent with the diagnosis of AD

• Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.

• Caregiver will participate and be able to attend clinic visits with patient.

Exclusion Criteria:

• Significant neurological disease other than AD, or a major psychiatric disorder

• Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)

• Woman of childbearing potential

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• bapineuzumab
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
• placebo
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Cordoba
Australia	Pfizer Investigational Site	Adelaide
Australia	Pfizer Investigational Site	Ballarat	Victoria
Australia	Pfizer Investigational Site	Gosford	New South Wales
Australia	Pfizer Investigational Site	Hornsby	New South Wales
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Australia	Pfizer Investigational Site	West Heidelberg	Victoria
Australia	Pfizer Investigational Site	Woodville South	South Australia
Austria	Pfizer Investigational Site	Graz
Austria	Pfizer Investigational Site	Klagenfurt
Austria	Pfizer Investigational Site	Wien
Austria	Pfizer Investigational Site	Wien
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Brugge
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Edegem
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Roeselare
Chile	Pfizer Investigational Site	Santiago
Chile	Pfizer Investigational Site	Santiago
Croatia	Pfizer Investigational Site	Zagreb
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Turku
France	Pfizer Investigational Site	Bordeaux Cedex
France	Pfizer Investigational Site	Bron
France	Pfizer Investigational Site	Caen
France	Pfizer Investigational Site	Caen
France	Pfizer Investigational Site	Colmar
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Nantes - Saint Herblain
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Poitiers
France	Pfizer Investigational Site	Reims
France	Pfizer Investigational Site	Rennes Cedex
France	Pfizer Investigational Site	Rouen
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Toulouse
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Bochum
Germany	Pfizer Investigational Site	Dresden
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Offenburg
Germany	Pfizer Investigational Site	Ulm
Italy	Pfizer Investigational Site	Ancona
Italy	Pfizer Investigational Site	Brescia
Italy	Pfizer Investigational Site	Catania
Italy	Pfizer Investigational Site	Catania
Italy	Pfizer Investigational Site	Chieti
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Monza
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Siena
Japan	Pfizer Investigational Site	Aichi
Japan	Pfizer Investigational Site	Chiba
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Gunma
Japan	Pfizer Investigational Site	Hiroshima
Japan	Pfizer Investigational Site	Hyogo
Japan	Pfizer Investigational Site	Iwate
Japan	Pfizer Investigational Site	Kagawa
Japan	Pfizer Investigational Site	Kanagawa
Japan	Pfizer Investigational Site	Kiyose	Tokyo
Japan	Pfizer Investigational Site	Kyoto
Japan	Pfizer Investigational Site	Nagano
Japan	Pfizer Investigational Site	Nagoya	Aichi,
Japan	Pfizer Investigational Site	Niigata
Japan	Pfizer Investigational Site	Okayama
Japan	Pfizer Investigational Site	Osaka
Japan	Pfizer Investigational Site	Shizuoka
Japan	Pfizer Investigational Site	Tokyo
Mexico	Pfizer Investigational Site	Aguascalientes
Mexico	Pfizer Investigational Site	Monterrey	Nuevo León
Netherlands	Pfizer Investigational Site	's-Hertogenbosch
Netherlands	Pfizer Investigational Site	Alkmaar
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Breda	Noord Brabant
Netherlands	Pfizer Investigational Site	Eindhoven
Netherlands	Pfizer Investigational Site	Hilversum	Noord Holland
Netherlands	Pfizer Investigational Site	Leeuwarden
Netherlands	Pfizer Investigational Site	Rotterdam
New Zealand	Pfizer Investigational Site	Auckland	NZ
New Zealand	Pfizer Investigational Site	Christchurch
Poland	Pfizer Investigational Site	Bydgoszcz
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Portugal	Pfizer Investigational Site	Amadora
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Lisboa
Serbia	Pfizer Investigational Site	Belgrade
Serbia	Pfizer Investigational Site	Kragujevac
Serbia	Pfizer Investigational Site	Novi Sad
Serbia	Pfizer Investigational Site	Sremska Kamenica
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Michalovce
Slovakia	Pfizer Investigational Site	Rimavska Sobota
South Africa	Pfizer Investigational Site	Bellville	Western Cape
South Africa	Pfizer Investigational Site	Durban	Kwa Zulu Natal
South Africa	Pfizer Investigational Site	Johannesburg	Gauteng
South Africa	Pfizer Investigational Site	Johannesburg	Gauteng
South Africa	Pfizer Investigational Site	Panorama	Western Cape
South Africa	Pfizer Investigational Site	Pretoria	Gauteng
Spain	Pfizer Investigational Site	Baracaldo	Vizcalla
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Burgos
Spain	Pfizer Investigational Site	Elche	Alicante
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Murcia
Spain	Pfizer Investigational Site	Palma de Mallorca	Islas Baleares
Spain	Pfizer Investigational Site	Palma de Mallorca	Islas Baleares
Spain	Pfizer Investigational Site	Plasencia	Caceres
Spain	Pfizer Investigational Site	San Sebastian	Pais Vasco
Spain	Pfizer Investigational Site	Terrassa	Barcelona
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Uppsala
Sweden	Pfizer Investigational Site	Uppsala
Switzerland	Pfizer Investigational Site	Basel	BS
Switzerland	Pfizer Investigational Site	Lausanne	VD
Switzerland	Pfizer Investigational Site	Les Acacias	GE
Switzerland	Pfizer Investigational Site	Thonex-Geneva
United Kingdom	Pfizer Investigational Site	Blackpool	Lancashire
United Kingdom	Pfizer Investigational Site	Bradford
United Kingdom	Pfizer Investigational Site	Brighton
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Newcastle upon Tyne
United Kingdom	Pfizer Investigational Site	Northampton
United Kingdom	Pfizer Investigational Site	Penarth
United Kingdom	Pfizer Investigational Site	Sheffield
United Kingdom	Pfizer Investigational Site	Sheffield
United Kingdom	Pfizer Investigational Site	Swindon
United Kingdom	Pfizer Investigational Site	Trafford Park	Manchester
United States	Pfizer Investigational Site	Abington	Pennsylvania
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Ann Arbor,	Michigan
United States	Pfizer Investigational Site	Atlantis	Florida
United States	Pfizer Investigational Site	Bennington	Vermont
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boulder	Colorado
United States	Pfizer Investigational Site	Carson	California
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Columbs	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dartmouth	Massachusetts
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Delray Beach	Florida
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	East Lansing	Michigan
United States	Pfizer Investigational Site	East Providence	Rhode Island
United States	Pfizer Investigational Site	Eatontown	New Jersey
United States	Pfizer Investigational Site	Edison	New Jersey
United States	Pfizer Investigational Site	Elk Grove Village	Illinois
United States	Pfizer Investigational Site	Fairfield	Connecticut
United States	Pfizer Investigational Site	Goodyear	Arizona
United States	Pfizer Investigational Site	Greenwich	Connecticut
United States	Pfizer Investigational Site	Hattiesburg	Mississippi
United States	Pfizer Investigational Site	Jenkintown	Pennsylvania
United States	Pfizer Investigational Site	Kansas	Kansas
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	Lake Charles	Louisiana
United States	Pfizer Investigational Site	Lawrenceville	Georgia
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Liverpool	New York
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Manchester	New Jersey
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	North Charleston	South Carolina
United States	Pfizer Investigational Site	Norwalk	Connecticut
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Palm Beach Gardens	Florida
United States	Pfizer Investigational Site	Pawtucket	Rhode Island
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Pittsfield	Massachusetts
United States	Pfizer Investigational Site	Port Charlotte	Florida
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Sarasota	Florida
United States	Pfizer Investigational Site	Silverton	Oregon
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Springfield	Massachusetts
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Chile,  Croatia,  Finland,  France,  Germany,  Italy,  Japan,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale-Cognitive Subscale Total Score		78 weeks	No
Primary	Disability Assessment for Dementia Total Score		78 weeks	No
Secondary	Brain Amyloid Burden		71 Weeks	No
Secondary	CSF Phospho-Tau level		71 Weeks	No
Secondary	MRI Brain Boundary Shift Integral		71 Weeks	No
Secondary	Divergence of effect		39 Weeks	No
Secondary	Time to progression		78 Weeks	No
Secondary	Dependence Scale		78 Weeks	No
Secondary	Proportion of responders		78 Weeks	No
Secondary	Clinical Dementia Rating Sum of Boxes		78 Weeks	No

External Links

•   To obtain contact information for a study center near you, click here.