Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers

NCT ID: NCT01005862

Last Updated: 2012-09-26

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-09-30

Brief Summary

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The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's disease antibody leucine ABeta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-04360365

Group Type EXPERIMENTAL

PF-04360365

Intervention Type BIOLOGICAL

10 mg/kg, single dose administered intravenously

Placebo

single dose administered intravenously

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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PF-04360365

10 mg/kg, single dose administered intravenously

Intervention Type BIOLOGICAL

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females of non-childbearing potential (age 50 and over for Alzheimer's disease patients; 21-45 for healthy volunteers)
* For patients with Alzheimer's Disease: 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) and Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
* Mini-mental status exam score greater than or equal to 20
* Rosen-Modified Hachinski Ischemia Score of \< or = 4
* On stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Countries

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United States Sweden

Related Links

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Other Identifiers

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A9951011

Identifier Type: -

Identifier Source: org_study_id