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Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease

NCT00722046

CompletedPhase 2

Sponsor: Pfizer

Conditions: Alzheimer's Disease

Interventions: PF-04360365 0.1 mg/kg, PF-04360365 0.5 mg/kg, PF-04360365 1 mg/kg, Placebo, PF-04360365 3 mg/kg

Countries: United States, Australia, Belgium, Canada, South Korea, United Kingdom

Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient 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 criterial 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 (42)
  • Peoria, Arizona, United States
  • Peoria, Arizona, United States
  • Phoenix, Arizona, United States
  • Miami, Florida, United States
  • South Miami, Florida, United States
  • South Miami, Florida, United States
  • South Miami, Florida, United States
  • Elk Grove Village, Illinois, United States
  • Elk Grove Village, Illinois, United States
  • Overland Park, Kansas, United States
  • Overland Park, Kansas, United States
  • Overland Park, Kansas, United States
  • Eatontown, New Jersey, United States
  • Oakhurst, New Jersey, United States
  • Providence, Rhode Island, United States
  • Adelaide, South Australia, Australia
  • Woodville South, South Australia, Australia
  • Heidelberg West, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • Antwerp, Belgium
  • Edegem, Belgium
  • Jette, Belgium
  • Leuven, Belgium
  • Vancouver, British Columbia, Canada
  • London, Ontario, Canada
  • Peterborough, Ontario, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Sherbrooke, Quebec, Canada
  • + 12 more on CT.gov