Back to results

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

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-04360365 1 mg/kg

PF-04360365 3 mg/kg

PF-04360365 5 mg/kg

PF-04360365 10 mg/kg

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring antibody amyloid Alzheimer's Disease AD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

PF-04360365 1 mg/kg

PF-04360365 3 mg/kg

PF-04360365 5 mg/kg

PF-04360365 10 mg/kg

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00733642

First Posted

August 11, 2008

Last Updated

July 24, 2009

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00733642

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

antibody amyloid Alzheimer's Disease AD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-04360365 1 mg/kg

Arm Type

Experimental

Arm Title

PF-04360365 3 mg/kg

Arm Type

Experimental

Arm Title

PF-04360365 5 mg/kg

Arm Type

Experimental

Arm Title

PF-04360365 10 mg/kg

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

PF-04360365 1 mg/kg

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

PF-04360365 3 mg/kg

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

PF-04360365 5 mg/kg

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

PF-04360365 10 mg/kg

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

Facility Name

Pfizer Investigational Site

City

Eatontown

State/Province

New Jersey

ZIP/Postal Code

07724

Country

United States

Facility Name

Pfizer Investigational Site

City

Oakhurst

State/Province

New Jersey

ZIP/Postal Code

07755

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9951008&StudyName=Single%20Dose%20Escalation%20Study%20of%20PF-04360365%20In%20Subjects%20With%20Mild%20To%20Moderate%20Alzheimer%27s%20Disease

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs