Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01369225
First received: May 10, 2011
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: AAB-003 (PF-05236812) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open-label Extension, Multiple-dose, Parallel Group Study to Investigate the Long-term Safety and Tolerability of AAB-003 (PF-05236812) Administered Intravenously in Subjects With Mild to Moderate Alzheimer's Disease Previously Treated With AAB-003 or Placebo in Protocol B2601001 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Adverse events, clinical laboratory results, vital signs, physical and neurological examinations, ECGs, Columbia Suicide Severity Rating Scale (C-SSRS), magnetic resonance imaging (MRI) of the brain. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The presence of anti-product antibodies to AAB-003 will be determined in serum [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Disability Assessment in Dementia (DAD) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Neuropsychiatric Inventory (NPI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Clinical Demential Rating Sum of Boxes (CDR-SB) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Mini Mental State Exam (MMSE) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- CSF abeta, tau, p-tau, AAB-003 concentrations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Plasma abeta concentrations and associated parameters (eg, Cmax, Tmax, AUClast, AUCinf, t1/2, as appropriate) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 104 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 0.5 mg/kg AAB-003 |
Drug: AAB-003 (PF-05236812)
0.5 mg/kg AAB-003, IV
|
| Experimental: 1 mg/kg AAB-003 |
Drug: AAB-003 (PF-05236812)
1 mg/kg AAB-003, IV
|
| Experimental: 2 mg/kg AAB-003 |
Drug: AAB-003 (PF-05236812)
2 mg/kg AAB-003, IV
|
| Experimental: 4 mg/kg AAB-003 |
Drug: AAB-003 (PF-05236812)
4 mg/kg AAB-003, IV
|
| Experimental: 8 mg/kg AAB-003 |
Drug: AAB-003 (PF-05236812)
8 mg/kg AAB-003, IV
|
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Successful completion of study B2601001
- MMSE 12 or greater
Exclusion Criteria:
- Study B2601001 Week 32 MRI with clinically important exclusionary findings.
- Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369225
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, Florida | |
| Pfizer Investigational Site | Active, not recruiting |
| Hallandale Beach, Florida, United States, 33009 | |
| Pfizer Investigational Site | Active, not recruiting |
| Ocala, Florida, United States, 34471 | |
| Pfizer Investigational Site | Active, not recruiting |
| Ocala, Florida, United States, 34481 | |
| United States, Georgia | |
| Pfizer Investigational Site | Active, not recruiting |
| Atlanta, Georgia, United States, 30308 | |
| United States, Maryland | |
| Pfizer Investigational Site | Completed |
| Bethesda, Maryland, United States, 20814 | |
| Pfizer Investigational Site | Completed |
| Rockville, Maryland, United States, 20850 | |
| United States, Michigan | |
| Pfizer Investigational Site | Recruiting |
| Kalamazoo, Michigan, United States, 49048 | |
| United States, Mississippi | |
| Pfizer Investigational Site | Recruiting |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| Pfizer Investigational Site | Active, not recruiting |
| Creve Coeur, Missouri, United States, 63141 | |
| Pfizer Investigational Site | Active, not recruiting |
| St. Louis, Missouri, United States, 63044 | |
| United States, New Jersey | |
| Pfizer Investigational Site | Completed |
| Eatontown, New Jersey, United States, 07724 | |
| Pfizer Investigational Site | Completed |
| Edison, New Jersey, United States, 08837 | |
| Pfizer Investigational Site | Completed |
| Oakhurst, New Jersey, United States, 07755 | |
| Korea, Republic of | |
| Pfizer Investigational Site | Active, not recruiting |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707 | |
| Pfizer Investigational Site | Recruiting |
| Incheon, Korea, Republic of, 400-711 | |
| Pfizer Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 136-705 | |
| Pfizer Investigational Site | Active, not recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Pfizer Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 143-914 | |
| Pfizer Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01369225 History of Changes |
| Other Study ID Numbers: | B2601003 |
| Study First Received: | May 10, 2011 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Randomized Safety Study Open Label |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013