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

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: PF-04494700 - Low Dose Arm; Drug: PF-04494700 - High Dose Arm; Drug: Placebo Comparator

• Registration Number: NCT00141661
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Study Start: 2005-10
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-19
• Last Update Posted: 2009-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Arm	PF-04494700 - Low Dose Arm	-
High Dose Arm	PF-04494700 - High Dose Arm	-
Placebo Control	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
Safety Measures include Adverse Events	Every Visit
Laboratory Tests	Every Office Visit
12-Lead Electrocardiogram	Every Office Visit
24-Hour 12-Lead Serial ECGs	Baseline, Study End

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Memphis, Tennessee, United States