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

NCT ID: NCT00733642

Last Updated: 2009-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-04360365 1 mg/kg

Group Type EXPERIMENTAL

PF-04360365 1 mg/kg

Intervention Type BIOLOGICAL

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

PF-04360365 3 mg/kg

Group Type EXPERIMENTAL

PF-04360365 3 mg/kg

Intervention Type BIOLOGICAL

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

PF-04360365 5 mg/kg

Group Type EXPERIMENTAL

PF-04360365 5 mg/kg

Intervention Type BIOLOGICAL

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

PF-04360365 10 mg/kg

Group Type EXPERIMENTAL

PF-04360365 10 mg/kg

Intervention Type BIOLOGICAL

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

Interventions

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PF-04360365 1 mg/kg

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

Intervention Type BIOLOGICAL

PF-04360365 3 mg/kg

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

Intervention Type BIOLOGICAL

PF-04360365 5 mg/kg

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

Intervention Type BIOLOGICAL

PF-04360365 10 mg/kg

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Glendale, California, United States

Site Status

Pfizer Investigational Site

Eatontown, New Jersey, United States

Site Status

Pfizer Investigational Site

Oakhurst, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A9951008

Identifier Type: -

Identifier Source: org_study_id

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