Status:
COMPLETED
Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
Lead Sponsor:
Pfizer
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00733642
Start Date
August 1 2008
End Date
July 1 2009
Last Update
July 28 2009
Active Locations (3)
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1
Pfizer Investigational Site
Glendale, California, United States, 91206
2
Pfizer Investigational Site
Eatontown, New Jersey, United States, 07724
3
Pfizer Investigational Site
Oakhurst, New Jersey, United States, 07755