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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease	Drug: PF-04494700 - Low Dose Arm; Drug: PF-04494700 - High Dose Arm; Drug: Placebo Comparator	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	67 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	October 2005
Actual Primary Completion Date :	June 2006
Actual Study Completion Date :	June 2006

Arms and Interventions

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

Outcome Measures

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Primary Outcome Measures :

1. Safety Measures include Adverse Events [ Time Frame: Every Visit ]
2. Laboratory Tests [ Time Frame: Every Office Visit ]
3. 12-Lead Electrocardiogram [ Time Frame: Every Office Visit ]
4. 24-Hour 12-Lead Serial ECGs [ Time Frame: Baseline, Study End ]

Secondary Outcome Measures :

1. 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 ]
2. Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL [ Time Frame: Screening Visit, Baseline, Study End ]
3. Pharmacokinetic Profile [ Time Frame: Baseline and Every Office Visit ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
United States, California
Pfizer Investigational Site
Fresno, California, United States, 93720
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
San Francisco, California, United States, 94118
United States, Florida
Pfizer Investigational Site
Fort Lauderdale, Florida, United States, 33321
Pfizer Investigational Site
Fort Myers, Florida, United States, 33912
Pfizer Investigational Site
Hallandale Beach, Florida, United States, 33009
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Largo, Florida, United States, 33773
Pfizer Investigational Site
Orlando, Florida, United States, 32806
Pfizer Investigational Site
West palm Beach, Florida, United States, 33407
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119

Sponsors and Collaborators

Pfizer

Trans Tech Pharmaceuticals

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00141661 History of Changes
Other Study ID Numbers:	B0341008; TTP488-201
First Posted:	September 1, 2005
Last Update Posted:	August 20, 2009
Last Verified:	August 2009

Keywords provided by Pfizer:

Interventional, Alzheimer, Safety and Tolerability

Additional relevant MeSH terms:

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