Single Dose Escalation Study of PF-04360365 In Subjects W... | NCT00733642

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

NCT00733642

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jul 28, 2009Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

PF-04360365 1 mg/kg
PF-04360365 3 mg/kg
PF-04360365 5 mg/kg
PF-04360365 10 mg/kg

Countries

United States

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

Jul 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

Aug 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Aug 11, 2008

First Submission Date that Met QC Criteria

Aug 11, 2008

First Posted Date

Aug 13, 2008Estimated

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

Jul 24, 2009

Last Update Posted Date

Jul 28, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 to determine whether single doses of PF-04360365 is safe and well tolerated in patients with 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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
PF-04360365 1 mg/kg	Experimental	Biological: PF-04360365 1 mg/kg
PF-04360365 3 mg/kg	Experimental	Biological: PF-04360365 3 mg/kg
PF-04360365 5 mg/kg	Experimental	Biological: PF-04360365 5 mg/kg
PF-04360365 10 mg/kg	Experimental	Biological: PF-04360365 10 mg/kg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-04360365 1 mg/kg	Biological	PF-04360365 1 mg/kg infused as a single dose	PF-04360365 1 mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.		6 months

Secondary Outcomes

Measure	Description	Time Frame
To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD.		6 months
To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure.		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

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		Glendale	California	91206	United States
Pfizer Investigational Site

References Module

Citations

Not provided

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