Back to resultsA Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04447943
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, PF-04447943, efficacy, safety, plasma concentrations
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
Sites / Locations
- Neurology Clinic, PC
- ATP Clinical Research, Inc.
- Southwestern Research Incorporated
- Pacific Coast Imaging (for Imaging only)
- The Southwest Institute for Clinical Research, Inc.
- Pacific Research Network (Satellite Site)
- Pacific Research Network, Inc. (Satellite Site)
- MD Clinical
- Compass Research, LLC
- Berma Research Group
- Joliet Center for Clinical Research
- Fort Wayne Neurological Center
- Agewell
- Four Rivers Clinical Research, Inc.
- Advanced MRI
- Lake Charles Clinical Trials, LLC
- Neurocare, Inc.
- Neurobehavioral Research Inc
- Behavioral Medical Research of Staten Island
- University of Pittsburgh Alzheimer's Disease Research Center
- Rhode Island Hospital, Alzheimer's Disease and Memory Disorders Center
- Neurology Clinic, PC
- Medical Arts Health Research Group
- Hamilton Health Sciences
- Kawartha Regional Memory Clinic
- Neuro Rive Sud Clinic
- Diex Recherche Inc.
- Psicomed Estudios Clinicos
- Centro Doctora Lissette Duque
- Psicomedica Research Group
- Hospital Del Salvador
- Neuroconsult
- Especialidades Medicas L y S
- Neuropsicologia Ltda.
- Hospital Base Valdivia
- Fakultni nemocnice
- Pardubicka krajska nemocnice, a.s.
- Pragtis, s.r.o.
- Fakultni nemocnice v Motole
- Psychiatry Trial, s.r.o.
- Psychiatricka ambulance
- Neurologie - EEG, s.r.o
- Centrum neurologicke pece, s.r.o.
- Psychiatricka ambulance
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PF-04447943
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
Secondary Outcome Measures
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
Clinical Global Impression - Improvement (CGI-I)
CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Neuropsychiatric Inventory (NPI) Total Score at Baseline
NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12
NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00930059
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2009 (Actual)
Primary Completion Date
September 22, 2010 (Actual)
Study Completion Date
September 22, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, PF-04447943, efficacy, safety, plasma concentrations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-04447943
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04447943
Intervention Description
tablets, 25 mg every 12 hours for 12 wks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo tablets, every 12 hours for 12 wks
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline
Description
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
Time Frame
Baseline (Day 1)
Title
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12
Description
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9
Description
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
Time Frame
Baseline, Week 3, 6, 9
Title
Clinical Global Impression - Improvement (CGI-I)
Description
CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Time Frame
Week 3, 6, 9, 12
Title
Neuropsychiatric Inventory (NPI) Total Score at Baseline
Description
NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.
Time Frame
Baseline
Title
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12
Description
NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.
Time Frame
Baseline, Week 3, 6, 9, 12
Other Pre-specified Outcome Measures:
Title
Number of Participants With Laboratory Test Abnormalities
Description
Criteria for laboratory test abnormality: a) Hematology: white blood cells (WBC) <0.6*lower limit of normal (LLN)/>1.5*upper limit of normal (ULN), hemoglobin, hematocrit, red blood cells (RBC), lymphocytes <0.8*LLN, total neutrophils <0.8*LLN/ >1.2*ULN, basophils, eosinophils, monocytes >1.2*ULN; b) Liver Function: total bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT[>0.3*ULN, total protein, albumin <0.8*LLN/ >1.2*ULN; c) Renal Function: creatinine >1.3*ULN, uric acid >1.2*ULN; d) Electrolytes: sodium <0.95*LLN/ >1.05*ULN, potassium, chloride, bicarbonate <0.9*LLN/ >1.1*ULN; e) Clinical Chemistry: glucose <0.6*LLN/ >1.5*ULN, glycosylated hemoglobin >1.3*ULN; f) Urinalysis: ketones, protein, blood/hemoglobin, urine glucose >=1, RBC, WBC >=6, hyaline casts >1; g) Hormones: tetraiodothyronine (T4), triiodothyronine (T3) and thyroid stimulating hormone (TSH) <0.8*LLN/1.2*ULN.
Time Frame
Baseline up to Week 12
Title
Number of Participants With Pre-defined Criteria for Electrocardiogram (ECG) Abnormalities
Description
Criteria for ECG (12-lead) abnormalities were as follow: 1) PR interval: greater than and equal to (>=) 300 milliseconds (msec), 2) PR interval: maximum increase from baseline >=25 percent (%) (if baseline PR interval greater than [>] 100 msec) or >=50% (if baseline PR interval less than or equal to [<=] 100 msec); 3) QRS complex: >=200 msec, 4) QRS complex: maximum increase from baseline >=25% or >=50%; 5) QT interval >=500 msec; 6) QT interval corrected using Bazett's formula (QTcB): 450 to less than (<) 480 msec, 7) QTcB: 480 to <500 msec, 8) QTcB: >=500 msec, 10) QTcB: 30 to <60 msec increase from baseline, 11) QTcB: >=60 msec increase from baseline; 9) QT interval corrected using the Fridericia's formula (QTcF): 450 to <480 msec, 10) QTcF: 480 to < 500 msec, 11) QTcF: >=500 msec, 12) QTcF: 30 to <60 msec increase from baseline, 13) QTcF: change>=60 msec increase from baseline.
Time Frame
Baseline up to Week 12
Title
Number of Participants With Abnormal Physical Examinations and Neurological Examinations
Description
The complete physical and neurological examination included examination of abdomen, ears, extremities, eyes, general, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, pulse, skin, throat, thyroid, and others. Abnormality was judged by investigator.
Time Frame
Screening (28 days before Baseline), Week 12
Title
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
C-SSRS assessed whether participant experienced the following: suicidal behavior which includes suicide attempt, interrupted attempt, aborted attempt, and preparatory acts towards imminent suicidal behavior (response of "Yes" on "preparatory acts or behavior"); suicidal ideation (response of "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent); self-injurious behavior (SIB), intent unknown (response of "Yes" on "Has subject engaged in Non-suicidal Self-Injurious Behavior?").
Time Frame
Screening, Baseline, Post-baseline (Week 1 up to 12)
Title
PF-04447943 Plasma Concentration
Time Frame
Pre-dose on Week 1; 0 to 3 hours following cognitive testing at Week 3, 6, 9, 12
Title
Number of Participants With Pre-defined Criteria of Vital Signs Abnormalities
Description
Pre-defined criteria vital signs abnormalities included maximum increase or decrease of greater than or equal to (>=) 30 millimeters of mercury (mmHg) from baseline for supine systolic blood pressure (SBP); maximum increase or decrease of >=20 mmHg from baseline for supine diastolic BP (DBP); maximum increase or decrease of >=30 mmHg from baseline for standing SBP; maximum increase or decrease of >=20 mmHg from baseline for standing DBP. Orthostatic hypotension was defined as a drop of more than 10 mmHg in diastolic BP or a drop of more than 20 mmHg in systolic BP within 3 minutes of standing from the supine position.
Time Frame
Baseline up to Week 12 for change in supine or standing blood pressure; Week 1, 3, 6, 9, 12 for orthostatic hypotension
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Neurology Clinic, PC
City
Northport
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Southwestern Research Incorporated
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Pacific Coast Imaging (for Imaging only)
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
The Southwest Institute for Clinical Research, Inc.
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Pacific Research Network (Satellite Site)
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Pacific Research Network, Inc. (Satellite Site)
City
Vista
State/Province
California
ZIP/Postal Code
92081
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Berma Research Group
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Joliet Center for Clinical Research
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Agewell
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Four Rivers Clinical Research, Inc.
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Advanced MRI
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Lake Charles Clinical Trials, LLC
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Neurocare, Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Neurobehavioral Research Inc
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Behavioral Medical Research of Staten Island
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
University of Pittsburgh Alzheimer's Disease Research Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital, Alzheimer's Disease and Memory Disorders Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Neurology Clinic, PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 3G8
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9C 7N4
Country
Canada
Facility Name
Kawartha Regional Memory Clinic
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 2P4
Country
Canada
Facility Name
Neuro Rive Sud Clinic
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Diex Recherche Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Psicomed Estudios Clinicos
City
Antofagasta
State/Province
II Region
Country
Chile
Facility Name
Centro Doctora Lissette Duque
City
Providencia
State/Province
RM
ZIP/Postal Code
7500617
Country
Chile
Facility Name
Psicomedica Research Group
City
Santiago
State/Province
RM
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Hospital Del Salvador
City
Santiago
State/Province
RM
ZIP/Postal Code
7500922
Country
Chile
Facility Name
Neuroconsult
City
Santiago
State/Province
RM
ZIP/Postal Code
7550112
Country
Chile
Facility Name
Especialidades Medicas L y S
City
Santiago
State/Province
RM
ZIP/Postal Code
7560356
Country
Chile
Facility Name
Neuropsicologia Ltda.
City
La Florida
State/Province
Santiago
ZIP/Postal Code
8260094
Country
Chile
Facility Name
Hospital Base Valdivia
City
Valdivia
State/Province
XIV Region
ZIP/Postal Code
5090145
Country
Chile
Facility Name
Fakultni nemocnice
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Pardubicka krajska nemocnice, a.s.
City
Pardubice
ZIP/Postal Code
53203
Country
Czechia
Facility Name
Pragtis, s.r.o.
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 08
Country
Czechia
Facility Name
Psychiatry Trial, s.r.o.
City
Praha 5
ZIP/Postal Code
15800
Country
Czechia
Facility Name
Psychiatricka ambulance
City
Praha 8
ZIP/Postal Code
180 00
Country
Czechia
Facility Name
Neurologie - EEG, s.r.o
City
Praha 8
ZIP/Postal Code
18000
Country
Czechia
Facility Name
Centrum neurologicke pece, s.r.o.
City
Rychnov nad Kneznou
ZIP/Postal Code
51601
Country
Czechia
Facility Name
Psychiatricka ambulance
City
Strakonice
ZIP/Postal Code
386 01
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0401005&StudyName=A%20Study%20Of%20PF-04447943%20Compared%20To%20Placebo%20In%20Subjects%20With%20Mild%20To%20Moderate%20Alzheimer%27s%20Disease
Description
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Learn more about this trial
A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
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