1 |
NCT00606476 |
Terminated |
AAB-001 (Bapineuzumab) Open-Label, Long-Term Extension Study in Patients With Mild to Moderate Alzheimer's Disease |
|
- Drug: Bapineuzumab (AAB-001)
|
Interventional
|
Phase 2 |
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- To assess the safety and tolerability of long-term treatment of bapineuzumab in subjects with AD.
- To evaluate the efficacy of long-term treatment of bapineuzumab in subjects with AD.
|
194 |
All |
Child, Adult, Older Adult |
NCT00606476 |
AAB-001-251 |
|
December 2006 |
September 2012 |
September 2012 |
February 4, 2008 |
November 25, 2013 |
|
- Janssen AI Investigational Site
Peoria, Arizona, United States - Janssen AI Investigational Site
Sun City, Arizona, United States - Janssen AI Investigational Site
Encino, California, United States - (and 26 more...)
|
|
2 |
NCT01254773 |
Completed |
Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease |
|
- Drug: Experimental Bapineuzumab
|
Interventional
|
Phase 2 |
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- To evaluate the effect of bapineuzumab administered subcutaneously (SC) at monthly intervals compared to placebo on cerebral amyloid burden in subjects with mild to moderate AD.
- To assess the safety of bapineuzumab administered SC at monthly intervals compared to placebo in subjects with mild to moderate AD
- To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints.
|
146 |
All |
50 Years to 89 Years (Adult, Older Adult) |
NCT01254773 |
AAB-001-SC-ALZ-2003 |
SUMMIT AD |
December 2010 |
January 2013 |
March 2013 |
December 7, 2010 |
May 9, 2014 |
|
- Janssen AI Investigational Site
Tucson, Arizona, United States - Janssen AI Investigational Site
Tucson, Arizona, United States - Janssen AI Investigational Site
La Habra, California, United States - (and 25 more...)
|
|
3 |
NCT00996918 |
Terminated Has Results |
A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients |
|
- Drug: Bapineuzumab 0.5 mg/kg
- Drug: Bapineuzumab 1.0 m/kg
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants Reporting a Serious Adverse Event.
- Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.
- Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.
- (and 6 more...)
|
198 |
All |
51 Years and older (Adult, Older Adult) |
NCT00996918 |
3133K1-3002 B2521003 |
|
December 2009 |
November 2012 |
November 2012 |
October 16, 2009 |
January 1, 2014 |
January 1, 2014 |
- Pfizer Investigational Site
Hornsby, New South Wales, Australia - Pfizer Investigational Site
Adelaide, South Australia, Australia - Pfizer Investigational Site
Woodville South, South Australia, Australia - (and 78 more...)
|
|
4 |
NCT00676143 |
Terminated Has Results |
Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients |
|
- Drug: bapineuzumab
- Drug: placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78
- Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78
- Change From Baseline in Brain Amyloid Burden at Week 71
- (and 14 more...)
|
1100 |
All |
50 Years to 88 Years (Adult, Older Adult) |
NCT00676143 |
3133K1-3001 B2521002 2007-005995-14 |
|
January 2008 |
October 2012 |
November 2012 |
May 12, 2008 |
June 10, 2016 |
June 10, 2016 |
- Center for Psychiatric Medicine
Birmingham, Alabama, United States - Participant and Clinical Interactions Resources
Birmingham, Alabama, United States - UAB Clinical Research Pharmacy-Russell Clinic
Birmingham, Alabama, United States - (and 284 more...)
|
|
5 |
NCT00998764 |
Terminated Has Results |
A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients |
|
- Drug: Bapineuzumab 0.5 mg/kg
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants Reporting a Serious Adverse Event
- Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78
- Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.
- (and 6 more...)
|
494 |
All |
51 Years to 90 Years (Adult, Older Adult) |
NCT00998764 |
3133K1-3003 B2521004 2009-015080-13 |
|
December 2009 |
October 2012 |
November 2012 |
October 20, 2009 |
January 1, 2016 |
January 1, 2016 |
- University Of Alabama at Birmingham
Birmingham, Alabama, United States - UAB Center for Psychiatric Medicine
Birmingham, Alabama, United States - University of Alabama at Birmingham
Birmingham, Alabama, United States - (and 180 more...)
|
|
6 |
NCT00667810 |
Terminated Has Results |
Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients |
|
- Drug: bapineuzumab
- Drug: placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78
- The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78
- The Change From Baseline in Brain Amyloid Burden at Week 71.
- (and 14 more...)
|
901 |
All |
50 Years to 89 Years (Adult, Older Adult) |
NCT00667810 |
3133K1-3000 B2521001 2007-005994-79 |
|
June 2008 |
October 2012 |
August 2013 |
April 28, 2008 |
January 8, 2016 |
January 8, 2016 |
- University of Alabama-Birmingham
Birmingham, Alabama, United States - Dedicated Clinical Research
Goodyear, Arizona, United States - Banner Alzheimer's Institute
Phoenix, Arizona, United States - (and 345 more...)
|
|
7 |
NCT00575055 |
Completed |
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier) |
|
- Drug: Bapineuzumab 0.5 mg/kg
- Drug: Placebo Control
- Drug: Bapineuzumab 1.0 m/kg
|
Interventional
|
Phase 3 |
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Cognitive and Functional
- Cognitive and Global
- Imaging and biochemical biomarkers of disease status
|
1121 |
All |
50 Years to 88 Years (Adult, Older Adult) |
NCT00575055 |
ELN115727-302 |
|
December 2007 |
April 2012 |
April 2012 |
December 17, 2007 |
November 25, 2013 |
|
- University of Alabama Hospital (UAB)
Birmingham, Alabama, United States - Dedicated Clinical Research, Inc.
Goodyear, Arizona, United States - Banner Alzheimer's Institute
Phoenix, Arizona, United States - (and 183 more...)
|
|
8 |
NCT00574132 |
Completed |
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier) |
|
- Drug: Bapineuzumab 0.5 mg/kg
- Drug: Placebo Control
- Drug: Bapineuzumab 1.0 m/kg
|
Interventional
|
Phase 3 |
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Cognitive and Functional
- Cognitive and Global
- Imaging and biochemical biomarkers of disease status
|
1331 |
All |
50 Years to 88 Years (Adult, Older Adult) |
NCT00574132 |
ELN115727-301 |
|
December 2007 |
June 2012 |
June 2012 |
December 17, 2007 |
November 25, 2013 |
|
- University of Alabama Hospital (UAB)
Birmingham, Alabama, United States - Dedicated Clinical Research, Inc.
Goodyear, Arizona, United States - Banner Alzheimer's Institute
Phoenix, Arizona, United States - (and 248 more...)
|
|
9 |
NCT00916617 |
Terminated Has Results |
Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab |
|
|
Interventional
|
Phase 2 |
- Pfizer
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings
- Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination
|
62 |
All |
50 Years to 89 Years (Adult, Older Adult) |
NCT00916617 |
3133L1-2204 B2521009 |
|
June 2009 |
September 2012 |
September 2012 |
June 9, 2009 |
June 1, 2017 |
June 1, 2017 |
- Banner Alzheimer's Institute
Phoenix, Arizona, United States - Pharmacology Research Institute
Encino, California, United States - Brain Matters Research
Delray Beach, Florida, United States - (and 13 more...)
|
|
10 |
NCT00937352 |
Terminated |
A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease |
|
|
Interventional
|
Phase 3 |
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments.
- To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.
|
896 |
All |
51 Years and older (Adult, Older Adult) |
NCT00937352 |
ELN115727-351 |
|
July 2009 |
September 2012 |
September 2012 |
July 13, 2009 |
December 20, 2013 |
|
- University of Alabama Hospital
Birmingham, Alabama, United States - Dedicated Clinical Research, Inc.
Goodyear, Arizona, United States - Banner Alzheimer's Institute
Phoenix, Arizona, United States - (and 188 more...)
|
|
11 |
NCT00112073 |
Completed |
AAB-001 in Patients With Mild to Moderate Alzheimer's Disease |
|
- Drug: bapineuzumab
- Other: placebo
|
Interventional
|
Phase 2 |
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- safety assessments
- blood levels of administered study drug
- cognitive and functional assessments
|
234 |
All |
50 Years to 85 Years (Adult, Older Adult) |
NCT00112073 |
AAB-001-201 |
|
April 2005 |
November 2008 |
December 2008 |
May 30, 2005 |
March 14, 2012 |
|
- Cleo Roberts Center for Clinical Research / Sun Health Research Institute
Sun City, Arizona, United States - UC Irvine
Irvine, California, United States - Pharmacology Research Institute
Los Alamitos, California, United States - (and 23 more...)
|
|
12 |
NCT00663026 |
Completed Has Results |
Study Evaluating Bapineuzumab In Alzheimer Disease Subjects |
|
- Drug: bapineuzumab
- Drug: placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Maximum Observed Serum Concentration (Cmax)
- Average Serum Concentration at Steady State (Cavg,ss)
- (and 4 more...)
|
79 |
All |
50 Years to 89 Years (Adult, Older Adult) |
NCT00663026 |
3133L1-2203 B2521008 |
|
November 2008 |
October 2010 |
October 2010 |
April 21, 2008 |
November 15, 2013 |
November 15, 2013 |
- Pfizer Investigational Site
Phoenix, Arizona, United States - Pfizer Investigational Site
Sun City, Arizona, United States - Pfizer Investigational Site
Encino, California, United States - (and 14 more...)
|
|
13 |
NCT00397891 |
Completed Has Results |
Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease |
|
|
Interventional
|
Phase 1 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
- Number of Participants With Clinically Significant Changes in Physical Examinations
- Number of Participants With Vital Signs of Potential Clinical Importance
- (and 17 more...)
|
80 |
All |
50 Years to 85 Years (Adult, Older Adult) |
NCT00397891 |
3133K1-102 |
|
October 2006 |
February 2010 |
February 2010 |
November 10, 2006 |
September 4, 2014 |
September 4, 2014 |
- Pfizer Investigational Site
Chiba, Japan - Pfizer Investigational Site
Saitama, Japan - Pfizer Investigational Site
Shizuoka, Japan - Pfizer Investigational Site
Tokyo, Japan
|
|
14 |
NCT01658722 |
Terminated |
Retrieval of Patient Information After Discontinuation |
|
|
Observational
|
|
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Pfizer
|
Industry |
- Time Perspective: Prospective
|
|
169 |
All |
55 Years and older (Adult, Older Adult) |
NCT01658722 |
AAB-001-ALZ-3300 |
RAPID |
December 2011 |
August 2012 |
August 2012 |
August 7, 2012 |
September 2, 2015 |
|
|
|
15 |
NCT00174525 |
Unknown † |
Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease |
|
|
Interventional
|
Phase 2 |
- Pharmacology Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Safety assessments
- Blood levels of administered study drug
- Cognitive and functional assessments
|
|
All |
50 Years to 85 Years (Adult, Older Adult) |
NCT00174525 |
PRI#585 |
|
April 2005 |
|
April 2008 |
September 15, 2005 |
May 9, 2012 |
|
- Pharmacology Research Institute
Los Alamitos, California, United States - Pharmacology Research Institute
Northridge, California, United States
|
|