A Phase I, Single IV Dose Of PF-04360365 In Adults With M... | NCT00455000

Studies
A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

NCT00455000

Sponsor

Pfizer

Status

Completed

Last Update Posted

Oct 14, 2009Estimated

Enrollment

37Actual

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

PF-04360365
Placebo

Countries

Australia
Canada
Sweden
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Mar 29, 2007

First Submission Date that Met QC Criteria

Mar 30, 2007

First Posted Date

Apr 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2009

Last Update Posted Date

Oct 14, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and well tolerated in Adults with Mild to Moderate Alzheimer's disease.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active treatment	Experimental	5 possible active doses	Biological: PF-04360365
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-04360365	Biological	Monoclonal antibody	Active treatment
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To examine the safety, tolerability, and pharmacokinetics of a single dose of PF-04360365 in subjects with mild to moderate AD for one year following dosing.		366 days

Secondary Outcomes

Measure	Description	Time Frame
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.		366 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or Females of non-childbearing potential, age 50-85
Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); and 2)Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
Mini-mental status exam score of 16-26 inclusive
Rosen-Modified Hachinski Ischemia Score < or = 4

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, extensive white matter abnormalities
History of autoimmune disorders
History of allergic or anaphylactic reactions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Heidelberg West	Victoria	3081	Australia
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C572721	ponezumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided