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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

NCT00945672

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