Clinical trial NCT00930059: A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
Official title: A PHASE 2 MULTICENTER, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF PF-04447943 IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
PF-04447943
efficacy
safety
plasma concentrations
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-30
Enrollment: 191
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in the plasma over the course of the study.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate Alzheimer's disease (MMSE 14-26)
* Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)

Exclusion Criteria:

* Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or memantine within 12 weeks of the start of the study
* Significant cardiovascular disease in the past 6 months
* Illness other than Alzheimer's disease that could contribute to cognitive impairment
* History of stroke or seizure disorder

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline
timeFrame: Baseline (Day 1)
measure: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9
timeFrame: Baseline, Week 3, 6, 9
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Week 3, 6, 9, 12
measure: Neuropsychiatric Inventory (NPI) Total Score at Baseline
timeFrame: Baseline
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12
timeFrame: Baseline, Week 3, 6, 9, 12
Other outcomes:
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline up to Week 12
measure: Number of Participants With Pre-defined Criteria for Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Week 12
measure: Number of Participants With Abnormal Physical Examinations and Neurological Examinations
timeFrame: Screening (28 days before Baseline), Week 12
measure: Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Screening, Baseline, Post-baseline (Week 1 up to 12)
measure: PF-04447943 Plasma Concentration
timeFrame: Pre-dose on Week 1; 0 to 3 hours following cognitive testing at Week 3, 6, 9, 12
measure: Number of Participants With Pre-defined Criteria of Vital Signs Abnormalities
timeFrame: Baseline up to Week 12 for change in supine or standing blood pressure; Week 1, 3, 6, 9, 12 for orthostatic hypotension
Locations:
city: Northport
country: United States
facility: Neurology Clinic, PC
state: Alabama
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Glendale
country: United States
facility: Southwestern Research Incorporated
state: California
city: Newport Beach
country: United States
facility: Pacific Coast Imaging (for Imaging only)
state: California
city: Rancho Mirage
country: United States
facility: The Southwest Institute for Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: Pacific Research Network (Satellite Site)
state: California
city: Vista
country: United States
facility: Pacific Research Network, Inc. (Satellite Site)
state: California
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Plantation
country: United States
facility: Berma Research Group
state: Florida
city: Joliet
country: United States
facility: Joliet Center for Clinical Research
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Indianapolis
country: United States
facility: Agewell
state: Indiana
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc.
state: Kentucky
city: Lake Charles
country: United States
facility: Advanced MRI
state: Louisiana
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials, LLC
state: Louisiana
city: Newton
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: Cedarhurst
country: United States
facility: Neurobehavioral Research Inc
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research of Staten Island
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Alzheimer's Disease Research Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital, Alzheimer's Disease and Memory Disorders Center
state: Rhode Island
city: Cordova
country: United States
facility: Neurology Clinic, PC
state: Tennessee
city: Kelowna
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Regional Memory Clinic
state: Ontario
city: Greenfield Park
country: Canada
facility: Neuro Rive Sud Clinic
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Inc.
state: Quebec
city: Antofagasta
country: Chile
facility: Psicomed Estudios Clinicos
state: II Region
city: Providencia
country: Chile
facility: Centro Doctora Lissette Duque
state: RM
city: Santiago
country: Chile
facility: Psicomedica Research Group
state: RM
city: Santiago
country: Chile
facility: Hospital Del Salvador
state: RM
city: Santiago
country: Chile
facility: Neuroconsult
state: RM
city: Santiago
country: Chile
facility: Especialidades Medicas L y S
state: RM
city: La Florida
country: Chile
facility: Neuropsicologia Ltda.
state: Santiago
city: Valdivia
country: Chile
facility: Hospital Base Valdivia
state: XIV Region
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice
city: Pardubice
country: Czechia
facility: Pardubicka krajska nemocnice, a.s.
city: Praha 2
country: Czechia
facility: Pragtis, s.r.o.
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha 5
country: Czechia
facility: Psychiatry Trial, s.r.o.
city: Praha 8
country: Czechia
facility: Psychiatricka ambulance
city: Praha 8
country: Czechia
facility: Neurologie - EEG, s.r.o
city: Rychnov nad Kneznou
country: Czechia
facility: Centrum neurologicke pece, s.r.o.
city: Strakonice
country: Czechia
facility: Psychiatricka ambulance
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: