A Study to Evaluate the Safety, Tolerability, and Blood Levels of PF-03654746 in Subjects With Mild to Moderate Alzheimer's Disease - Full Text View

Purpose

This is a study to evaluate the safety, tolerability and blood levels of PF-03654746 in subjects will mild to moderate Alzheimer's disease.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: PF-03654746 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 1, Double-Blind, Placebo-Controlled, Sponsor-Open, Randomized, Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-03654746 in Mild to Moderate Alzheimer's Disease Patients on Stable Donepezil Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical examinations, MOS-SS outcomes, NPI, MMSE, and adverse events [ Time Frame: screening to day 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Plasma concentrations of PF 03654746 over time. [ Time Frame: Days 5, 10, 15, 20, 25, and 30 ] [ Designated as safety issue: No ]
Plasma concentrations of donepezil over time. [ Time Frame: Days 0 and 30 ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	December 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PF-03654746	Drug: PF-03654746 PF-03654746 capsule of 0.25 mg, 0.5 mg, and 1.0 mg strength. Drug is dosed orally once a day. Forced titration dosing for the first 15 days of the study being at 0.25 mg for 5 days, then 0.5 mg for days 6-10, then 1.0 mg for days 11-15. Flexible dosing for the next 15 days depending on tolerability and safety assessments done by the investigator.
Placebo Comparator: Placebo	Drug: Placebo Matching placebo capsules to PF-03654746 with strengths of 0.25 mg, 0.5 mg, and 1.0 mg. Drug is dosed orally once a day. Forced titration dosing for the first 15 days of the study being at 0.25 mg for 5 days, then 0.5 mg for days 6-10, then 1.0 mg for days 11-15. Flexible dosing for the next 15 days depending on tolerability and safety assessments done by the investigator.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Dementia other than Alzheimer's disease
Clinically significant cardiovascular disease in the past 6 months prior to screening
Creatinine clearance <30 mL/min

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028911

Locations

United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67207
Pfizer Investigational Site
Wichita, Kansas, United States, 67211

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01028911 History of Changes
Other Study ID Numbers:	A8801016
Study First Received:	December 7, 2009
Last Updated:	July 27, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Phase 1 Alzheimer's disease Safety Tolerability Pharmacokinetics

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013