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

Pfizer1 site in 1 country67 target enrollmentOctober 2005

ConditionsAlzheimer Disease

InterventionsPF-04494700 - Low Dose Arm PF-04494700 - High Dose Arm Placebo Comparator

DrugsPF-04494700 - Low Dose Arm PF-04494700 - High Dose Arm Placebo Comparator

Overview

Phase: Phase 2
Intervention: PF-04494700 - Low Dose Arm
Conditions: Alzheimer Disease
Sponsor: Pfizer
Enrollment: 67
Locations: 1
Primary Endpoint: Safety Measures include Adverse Events
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

June 2006

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

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.

Arms & Interventions

Low Dose Arm

Intervention: PF-04494700 - Low Dose Arm

High Dose Arm

Intervention: PF-04494700 - High Dose Arm

Placebo Control

Intervention: Placebo Comparator

Outcomes

Primary Outcomes

Safety Measures include Adverse Events

Time Frame: Every Visit

Laboratory Tests

Time Frame: Every Office Visit

12-Lead Electrocardiogram

Time Frame: Every Office Visit

24-Hour 12-Lead Serial ECGs

Time Frame: Baseline, Study End

Secondary Outcomes

Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta(Baseline, Visit 5, Study End)
Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL(Screening Visit, Baseline, Study End)
Pharmacokinetic Profile(Baseline and Every Office Visit)