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OpenTrials
Completed

NCT Number: NCT00733642

Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

PF-04360365 1 mg/kg

Biological

PF-04360365 1 mg/kg infused as a single dose

PF-04360365 3 mg/kg

Biological

PF-04360365 3 mg/kg infused as a single dose

PF-04360365 5 mg/kg

Biological

PF-04360365 5 mg/kg infused as a single dose

PF-04360365 10 mg/kg

Biological

PF-04360365 10 mg/kg infused as a single dose

Primary outcomes

  1. To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.

    Time frame: 6 months

Secondary outcomes

  1. To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD.

    Time frame: 6 months

  2. To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 13, 2008
Registry last updated
Jul 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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