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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141661
• Other study ID #: B0341008
• Secondary ID: TTP488-201
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2005
• Last updated: August 19, 2009
• Start date: October 2005
• Est. completion date: June 2006

Study information

• Verified date: August 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• PF-04494700 - Low Dose Arm
30 mg loading dose for 6 days, followed by 10 mg daily
• PF-04494700 - High Dose Arm
60 mg loading dose for 6 days, followed by 20 mg daily
• Placebo Comparator
Matching placebo.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Fort Myers	Florida
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Hallandale Beach	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Largo	Florida
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Sun City	Arizona
United States	Pfizer Investigational Site	West palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Trans Tech Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Measures include Adverse Events		Every Visit	Yes
Primary	Laboratory Tests		Every Office Visit	Yes
Primary	12-Lead Electrocardiogram		Every Office Visit
Primary	24-Hour 12-Lead Serial ECGs		Baseline, Study End	Yes
Secondary	Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta		Baseline, Visit 5, Study End	No
Secondary	Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL		Screening Visit, Baseline, Study End	No
Secondary	Pharmacokinetic Profile		Baseline and Every Office Visit	No

External Links

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