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A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-04494700 - Low Dose Arm
PF-04494700 - High Dose Arm
Placebo Comparator
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Interventional, Alzheimer, Safety and Tolerability

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of probably Alzheimer's disease for at least 1 year. Mini Mental State Exam (MMSE) score between 12-26 at screening. Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months. Exclusion Criteria: Current evidence of a neurological or psychiatric illness that could contribute to dementia. Living alone. Poorly controlled high blood pressure.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low Dose Arm

High Dose Arm

Placebo Control

Arm Description

Outcomes

Primary Outcome Measures

Safety Measures include Adverse Events
Laboratory Tests
12-Lead Electrocardiogram
24-Hour 12-Lead Serial ECGs

Secondary Outcome Measures

Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta
Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL
Pharmacokinetic Profile

Full Information

First Posted
August 30, 2005
Last Updated
August 19, 2009
Sponsor
Pfizer
Collaborators
Trans Tech Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00141661
Brief Title
A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study in Subjects With Mild to Moderate Dementia of the Alzheimer's Type to Evaluate the Safety and Tolerability of Two 10-Week Dose Regimens of Orally-Administered PF-04494700
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer
Collaborators
Trans Tech Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Interventional, Alzheimer, Safety and Tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Arm
Arm Type
Experimental
Arm Title
High Dose Arm
Arm Type
Experimental
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04494700 - Low Dose Arm
Intervention Description
30 mg loading dose for 6 days, followed by 10 mg daily
Intervention Type
Drug
Intervention Name(s)
PF-04494700 - High Dose Arm
Intervention Description
60 mg loading dose for 6 days, followed by 20 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Matching placebo.
Primary Outcome Measure Information:
Title
Safety Measures include Adverse Events
Time Frame
Every Visit
Title
Laboratory Tests
Time Frame
Every Office Visit
Title
12-Lead Electrocardiogram
Time Frame
Every Office Visit
Title
24-Hour 12-Lead Serial ECGs
Time Frame
Baseline, Study End
Secondary Outcome Measure Information:
Title
Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta
Time Frame
Baseline, Visit 5, Study End
Title
Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL
Time Frame
Screening Visit, Baseline, Study End
Title
Pharmacokinetic Profile
Time Frame
Baseline and Every Office Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of probably Alzheimer's disease for at least 1 year. Mini Mental State Exam (MMSE) score between 12-26 at screening. Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months. Exclusion Criteria: Current evidence of a neurological or psychiatric illness that could contribute to dementia. Living alone. Poorly controlled high blood pressure.
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
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Pfizer Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Pfizer Investigational Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Pfizer Investigational Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Pfizer Investigational Site
City
West palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=TTP488-201&StudyName=A%20Safety%20and%20Tolerability%20%20Evaluation%20of%20Two%2010-Week%20Dose%20Regimens%20of%20Orally-Administereed%20PF-04494700%20in%20Alzheimer%27s%20Patients
Description
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A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients

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