Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00733642
First received: August 11, 2008
Last updated: July 24, 2009
Last verified: July 2009
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Purpose
The purpose of this study is to determine whether single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Biological: PF-04360365 1 mg/kg Biological: PF-04360365 3 mg/kg Biological: PF-04360365 5 mg/kg Biological: PF-04360365 10 mg/kg |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects 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 subjects with mild-to-moderate AD. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | August 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-04360365 1 mg/kg |
Biological: PF-04360365 1 mg/kg
PF-04360365 1 mg/kg infused as a single dose
|
| Experimental: PF-04360365 3 mg/kg |
Biological: PF-04360365 3 mg/kg
PF-04360365 3 mg/kg infused as a single dose
|
| Experimental: PF-04360365 5 mg/kg |
Biological: PF-04360365 5 mg/kg
PF-04360365 5 mg/kg infused as a single dose
|
| Experimental: PF-04360365 10 mg/kg |
Biological: PF-04360365 10 mg/kg
PF-04360365 10 mg/kg infused as a single dose
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female (of non-child bearing potential) subjects ages ≥50 years of age.
- Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.
- MMSE score of 16-26 inclusive.
- Rosen-Modified Hachinski Ischemia Score ≤4.
- On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing.
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.
- History of allergic or anaphylactic reactions.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733642
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Glendale, California, United States, 91206 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Eatontown, New Jersey, United States, 07724 | |
| Pfizer Investigational Site | |
| Oakhurst, New Jersey, United States, 07755 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00733642 History of Changes |
| Other Study ID Numbers: | A9951008 |
| Study First Received: | August 11, 2008 |
| Last Updated: | July 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
antibody amyloid Alzheimer's Disease AD |
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 May 16, 2013