Trial record 4 of 8 for:
PF-04360365
A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00607308
First received: January 22, 2008
Last updated: December 6, 2010
Last verified: December 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Biological: PF-04360365 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
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:
- To examine the safety and tolerability of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD for one year following dosing. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | February 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 0.1 mg/kg |
Biological: PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
|
| Experimental: 0.5 mg/kg |
Biological: PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
|
| Experimental: 1 mg/kg |
Biological: PF-04360365
Single dose of 1 mg/kg IV on Day 1
|
| Experimental: 5 mg/kg |
Biological: PF-04360365
Single dose of 5 mg/kg IV on Day 1
|
| Placebo Comparator: Placebo |
Drug: Placebo
Single dose of placebo IV on Day 1
|
| Experimental: 10 mg/kg |
Biological: PF-04360365
Single dose of 10 mg/kg IV on Day 1
|
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Japanese male or females of non-childbearing potential, ages 50-85
- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: (1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) 2) Text Revision of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
- Mini-Mental Status Exam score of 16-26 inclusive
- Rosen-Modified Hachinski Ischemia score < or = 4
Exclusion Criteria:
- Diagnosis or history of other dementia or neurodegenerative disorders
- Diagnosis or history of clinically significant cerebrovascular disease
- Specific findings on magnetic resonance imaging (MRI): cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
- History of autoimmune disorders
- History of allergic or anaphylactic reactions
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607308
Locations
| Japan | |
| Pfizer Investigational Site | |
| Hirosaki, Aomori, Japan | |
| Pfizer Investigational Site | |
| Fukuoka-shi, Fukuoka, Japan | |
| Pfizer Investigational Site | |
| Fukuyama city, Hiroshima, Japan | |
| Pfizer Investigational Site | |
| Tsukuba, Ibaraki, Japan | |
| Pfizer Investigational Site | |
| Niigata-shi, Niigata, Japan | |
| Pfizer Investigational Site | |
| Bunkyo-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Kodaira, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Kanazawa, Japan | |
| Pfizer Investigational Site | |
| Kyoto, Japan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00607308 History of Changes |
| Other Study ID Numbers: | A9951005 |
| Study First Received: | January 22, 2008 |
| Last Updated: | December 6, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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