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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01028911
First received: December 7, 2009
Last updated: July 27, 2010
Last verified: July 2010
  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:


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

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Probable Alzheimer's disease
  • Mini Mental State Examination score 18-26 inclusive
  • Aged 55-85

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 April 17, 2014