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A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
CompletedPhase 2
Sponsor: Pfizer
Conditions: Alzheimer's Disease
Interventions: PF-04360365 10 mg/kg, PF-04360365 7.5 mg/kg, placebo
Countries: Sweden
The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.
Eligibility overview
Sex: ALL
Age: 50 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Males or females of non childbearing potential, age \> or = 50. * 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). * Diagnostic and Statistical Manual of Mental Disorders (DSM IV). * Mini-mental status exam score of 16-26 inclusive. * Rosen-Modified Hachinski Ischemia Score of \< or = 4. Exclusion Criteria: * 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.
Locations (4)
- Gothenburg, Sweden
- Malmö, Sweden
- Mölndal, Sweden
- Stockholm, Sweden