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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 |
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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 Biological: PF-04360365 3 mg/kg Biological: PF-04360365 8.5 mg/kg |
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: | 175 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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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PF-04360365 3 mg/kg: Experimental |
Biological: PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
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PF-04360365 8.5 mg/kg: Experimental |
Biological: PF-04360365 8.5 mg/kg
8.5 mg/kg 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 |
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: | September 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00722046 History of Changes |
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 |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |