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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00722046 |
Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Biological: PF-04360365 0.1 mg/kg Biological: PF-04360365 0.5 mg/kg Biological: PF-04360365 1 mg/kg Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study |
Official Title: | A Phase 2 Multicenter, Randomized, Double Blind, Placebo-Controlled Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease |
Estimated Enrollment: | 100 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
PF-04360365 0.1 mg/kg: Experimental |
Biological: PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
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PF-04360365 0.5 mg/kg: Experimental |
Biological: PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)
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PF-04360365 1 mg/kg: Experimental |
Biological: PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
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Placebo: Placebo Comparator |
Drug: Placebo
Placebo every 60 days (10 doses total)
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of probable Alzheimer's disease, consistent with criterial from both:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, Arizona | |
Pfizer Investigational Site | Not yet recruiting |
Phoenix, Arizona, United States, 85013 | |
United States, Florida | |
Pfizer Investigational Site | Recruiting |
Miami, Florida, United States, 33176 | |
Pfizer Investigational Site | Recruiting |
South Miami, Florida, United States, 33143 | |
United States, Illinois | |
Pfizer Investigational Site | Recruiting |
Elk Grove Village, Illinois, United States, 60007 | |
United States, Kansas | |
Pfizer Investigational Site | Recruiting |
Overland Park, Kansas, United States, 66211 | |
Pfizer Investigational Site | Recruiting |
Overland Park, Kansas, United States, 66212 | |
Australia, Victoria | |
Pfizer Investigational Site | Recruiting |
Heidelberg West, Victoria, Australia, 3084 | |
Canada, Ontario | |
Pfizer Investigational Site | Recruiting |
Toronto, Ontario, Canada, M3B 2S7 | |
Pfizer Investigational Site | Recruiting |
Peterborough, Ontario, Canada, K9H 2P4 | |
Canada, Quebec | |
Pfizer Investigational Site | Recruiting |
Sherbrooke, Quebec, Canada, J1H 1Z1 | |
United Kingdom, Wiltshire | |
Pfizer Investigational Site | Not yet recruiting |
Swindon, Wiltshire, United Kingdom, SN3 6BB | |
Pfizer Investigational Site | Not yet recruiting |
Swindon, Wiltshire, United Kingdom, SN3 6BW |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A9951002 |
Study First Received: | July 23, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00722046 |
Health Authority: | United States: Food and Drug Administration |
Alzheimer's disease, antibody, amyloid |
Antibodies Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Immunoglobulins Delirium |
Nervous System Diseases Tauopathies |