A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease

NCT00566397 | Completed Phase 2 DMC

• 1 other identifier: B0341002
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 62

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.

Conditions

Alzheimer's Disease

Keywords

RI RI Study Rage Inhibitors

Outcome Measures

Primary Outcomes (2)

• Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment.

  18 Month

• Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI).

  18 Month

Secondary Outcomes (3)

• Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET)

  18 Month

• Evaluate the potential dose response of PF 04494700

  18 Month

• Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints

  18 Month

Study Arms (3)

1

EXPERIMENTAL

Drug: PF-04494700

2

EXPERIMENTAL

Drug: PF-04494700

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PF-04494700 DRUG

15 mg for 6 days followed by daily dosing of 5mg

1

Placebo DRUG

Placebo

3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.
• Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization

You may not qualify if:

• Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia.
• Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations.
• Evidence or history of diabetes mellitus Type 1 or Type 2.
• History or symptoms of autoimmune disorders.

Sponsors & Collaborators

• Pfizer: lead
• Alzheimer's Disease Cooperative Study (ADCS): collaborator

Study Sites (62)

Pfizer Investigational Site

Phoenix, Arizona, 85006, United States

Location

Pfizer Investigational Site

Sun City, Arizona, 85351, United States

Location

Pfizer Investigational Site

Irvine, California, 92697-1385, United States

Location

Pfizer Investigational Site

Irvine, California, 92697-3959, United States

Location

Pfizer Investigational Site

Irvine, California, 92697-4285, United States

Location

Pfizer Investigational Site

Irvine, California, 92697, United States

Location

Pfizer Investigational Site

La Jolla, California, 92037, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90033, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Pfizer Investigational Site

Martinez, California, 94553, United States

Location

Pfizer Investigational Site

Newport Beach, California, 92660, United States

Location

Pfizer Investigational Site

Orange, California, 92868, United States

Location

Pfizer Investigational Site

Palo Alto, California, 94304, United States

Location

Pfizer Investigational Site

Sacramento, California, 95817, United States

Location

Pfizer Investigational Site

San Diego, California, 92103-8749, United States

Location

Pfizer Investigational Site

San Diego, California, 92103, United States

Location

Pfizer Investigational Site

San Diego, California, 92128, United States

Location

Pfizer Investigational Site

San Francisco, California, 94117, United States

Location

Pfizer Investigational Site

San Francisco, California, 94121, United States

Location

Pfizer Investigational Site

San Francisco, California, 94143, United States

Location

Pfizer Investigational Site

Vista, California, 92081, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06509, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06510, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06520, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20057, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20060, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32224, United States

Location

Pfizer Investigational Site

Miami Beach, Florida, 33140, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33613, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30329-5102, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60611, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40504, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40536, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21224, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

Grand Rapids, Michigan, 49503, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63108, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89106, United States

Location

Pfizer Investigational Site

New York, New York, 10016, United States

Location

Pfizer Investigational Site

New York, New York, 10029, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

Rochester, New York, 14620, United States

Location

Pfizer Investigational Site

Beachwood, Ohio, 44122, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97201, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Pfizer Investigational Site

Providence, Rhode Island, 02903, United States

Location

Pfizer Investigational Site

Charleston, South Carolina, 29425, United States

Location

Pfizer Investigational Site

North Charleston, South Carolina, 29406-6076, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37208, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Houston, Texas, 77098, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84108, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98104, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98108, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53705, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: December 3, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

US (62)