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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00607308 |
Examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Biological: PF-04360365 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study |
Official Title: | A Phase 1, Randomized, Placebo-Controlled, Double Blind, Dose-Escalation, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease |
Estimated Enrollment: | 16 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
0.1 mg/kg: Experimental |
Biological: PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
|
0.5 mg/kg: Experimental |
Biological: PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
|
1 mg/kg: Experimental |
Biological: PF-04360365
Single dose of 1 mg/kg IV on Day 1
|
5 mg/kg: Experimental |
Biological: PF-04360365
Single dose of 5 mg/kg IV on Day 1
|
Placebo: Placebo Comparator |
Drug: Placebo
Single dose of placebo IV on Day 1
|
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Japan | |
Pfizer Investigational Site | Recruiting |
Kanazawa, Japan | |
Pfizer Investigational Site | Recruiting |
Kyoto, Japan | |
Japan, Aomori | |
Pfizer Investigational Site | Recruiting |
Hirosaki, Aomori, Japan | |
Japan, Fukuoka | |
Pfizer Investigational Site | Recruiting |
Fukuoka-shi, Fukuoka, Japan | |
Japan, Hiroshima | |
Pfizer Investigational Site | Recruiting |
Fukuyama city, Hiroshima, Japan | |
Japan, Ibaraki | |
Pfizer Investigational Site | Not yet recruiting |
Tsukuba, Ibaraki, Japan | |
Japan, Niigata | |
Pfizer Investigational Site | Recruiting |
Niigata-shi, Niigata, Japan | |
Japan, TOKYO | |
Pfizer Investigational Site | Recruiting |
Bunkyo-ku, TOKYO, Japan | |
Japan, Tokyo | |
Pfizer Investigational Site | Recruiting |
Kodaira, Tokyo, Japan |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trials Disclosure Group ) |
Study ID Numbers: | A9951005 |
Study First Received: | January 22, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00607308 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |