Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Alzheimer's Disease
In brief
The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.
Key facts
- Study ID
- NCT01005862
- Run by
- Pfizer
- People needed
- 17
- Starts
- 2010-03-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2012-09-26
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males or females of non-childbearing potential (age 50 and over for Alzheimer's disease patients; 21-45 for healthy volunteers)
- For patients with Alzheimer's Disease: Diagnosis of probable Alzheimer's disease, consistent with criteria from both National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Mini-mental status exam score greater than or equal to 20
- Rosen-Modified Hachinski Ischemia Score of < or = 4
- On stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment
You may not qualify if…
- Diagnosis or history of other demential 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
Where it is running
- Pfizer Investigational Site — Glendale, California, United States
- Pfizer Investigational Site — St Louis, Missouri, United States
- Pfizer Investigational Site — Stockholm, Sweden
Full record on ClinicalTrials.gov
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