- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00930059
A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
October 28, 2020 updated by: Pfizer
A PHASE 2 MULTICENTER, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF PF-04447943 IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
191
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 3G8
- Medical Arts Health Research Group
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Ontario
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Hamilton, Ontario, Canada, L9C 7N4
- Hamilton Health Sciences
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Peterborough, Ontario, Canada, K9H 2P4
- Kawartha Regional Memory Clinic
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2J2
- Neuro Rive Sud Clinic
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Sherbrooke, Quebec, Canada, J1H 1Z1
- Diex Recherche Inc.
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II Region
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Antofagasta, II Region, Chile
- Psicomed Estudios Clínicos
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RM
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Providencia, RM, Chile, 7500617
- Centro Doctora Lissette Duque
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Santiago, RM, Chile, 7500922
- Hospital del Salvador
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Santiago, RM, Chile, 7500710
- Psicomedica Research Group
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Santiago, RM, Chile, 7550112
- Neuroconsult
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Santiago, RM, Chile, 7560356
- Especialidades Medicas L Y S
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Santiago
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La Florida, Santiago, Chile, 8260094
- Neuropsicología Ltda.
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XIV Region
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Valdivia, XIV Region, Chile, 5090145
- Hospital Base Valdivia
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Hradec Kralove, Czechia, 500 05
- Fakultní nemocnice
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Pardubice, Czechia, 53203
- Pardubicka krajska nemocnice, a.s.
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Praha 2, Czechia, 120 00
- Pragtis, s.r.o.
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Praha 5, Czechia, 150 08
- Fakultni nemocnice v Motole
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Praha 5, Czechia, 15800
- Psychiatry Trial, s.r.o.
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Praha 8, Czechia, 180 00
- Psychiatricka ambulance
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Praha 8, Czechia, 18000
- Neurologie - EEG, s.r.o
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Rychnov nad Kneznou, Czechia, 51601
- Centrum neurologicke pece, s.r.o.
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Strakonice, Czechia, 386 01
- Psychiatricka ambulance
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Alabama
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Northport, Alabama, United States, 35476
- Neurology Clinic, PC
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California
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Costa Mesa, California, United States, 92626
- ATP Clinical Research, Inc.
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Glendale, California, United States, 91204
- Southwestern Research Incorporated
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Newport Beach, California, United States, 92663
- Pacific Coast Imaging (for Imaging only)
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Rancho Mirage, California, United States, 92270
- The Southwest Institute for Clinical Research, Inc.
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San Diego, California, United States, 92128
- Pacific Research Network (Satellite Site)
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Vista, California, United States, 92081
- Pacific Research Network, Inc. (Satellite Site)
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Florida
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Hallandale Beach, Florida, United States, 33009
- MD Clinical
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Orlando, Florida, United States, 32806
- Compass Research, LLC
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Plantation, Florida, United States, 33317
- Berma Research Group
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Illinois
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Joliet, Illinois, United States, 60435
- Joliet Center for Clinical Research
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Indiana
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Fort Wayne, Indiana, United States, 46805
- Fort Wayne Neurological Center
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Indianapolis, Indiana, United States, 46260
- Agewell
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Kentucky
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Paducah, Kentucky, United States, 42003
- Four Rivers Clinical Research, Inc.
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Louisiana
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Lake Charles, Louisiana, United States, 70601
- Lake Charles Clinical Trials, LLC
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Lake Charles, Louisiana, United States, 70601
- Advanced MRI
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Massachusetts
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Newton, Massachusetts, United States, 02459
- Neurocare, Inc.
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New York
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Cedarhurst, New York, United States, 11516
- Neurobehavioral Research Inc
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Staten Island, New York, United States, 10305
- Behavioral Medical Research Of Staten Island
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Alzheimer's Disease Research Center
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital, Alzheimer's Disease and Memory Disorders Center
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Tennessee
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Cordova, Tennessee, United States, 38018
- Neurology Clinic, PC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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matching placebo tablets, every 12 hours for 12 wks
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Experimental: PF-04447943
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tablets, 25 mg every 12 hours for 12 wks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline
Time Frame: Baseline (Day 1)
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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.
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Baseline (Day 1)
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Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12
Time Frame: Baseline, Week 12
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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.
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9
Time Frame: Baseline, Week 3, 6, 9
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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.
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Baseline, Week 3, 6, 9
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Clinical Global Impression - Improvement (CGI-I)
Time Frame: Week 3, 6, 9, 12
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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.
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Week 3, 6, 9, 12
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Neuropsychiatric Inventory (NPI) Total Score at Baseline
Time Frame: Baseline
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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.
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Baseline
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Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12
Time Frame: Baseline, Week 3, 6, 9, 12
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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.
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Baseline, Week 3, 6, 9, 12
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Laboratory Test Abnormalities
Time Frame: Baseline up to Week 12
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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.
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Baseline up to Week 12
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Number of Participants With Pre-defined Criteria for Electrocardiogram (ECG) Abnormalities
Time Frame: Baseline up to Week 12
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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.
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Baseline up to Week 12
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Number of Participants With Abnormal Physical Examinations and Neurological Examinations
Time Frame: Screening (28 days before Baseline), Week 12
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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.
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Screening (28 days before Baseline), Week 12
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Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Screening, Baseline, Post-baseline (Week 1 up to 12)
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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?").
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Screening, Baseline, Post-baseline (Week 1 up to 12)
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PF-04447943 Plasma Concentration
Time Frame: Pre-dose on Week 1; 0 to 3 hours following cognitive testing at Week 3, 6, 9, 12
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Pre-dose on Week 1; 0 to 3 hours following cognitive testing at Week 3, 6, 9, 12
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Number of Participants With Pre-defined Criteria of Vital Signs Abnormalities
Time Frame: Baseline up to Week 12 for change in supine or standing blood pressure; Week 1, 3, 6, 9, 12 for orthostatic hypotension
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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.
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Baseline up to Week 12 for change in supine or standing blood pressure; Week 1, 3, 6, 9, 12 for orthostatic hypotension
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2009
Primary Completion (Actual)
September 22, 2010
Study Completion (Actual)
September 22, 2010
Study Registration Dates
First Submitted
June 29, 2009
First Submitted That Met QC Criteria
June 29, 2009
First Posted (Estimate)
June 30, 2009
Study Record Updates
Last Update Posted (Actual)
November 19, 2020
Last Update Submitted That Met QC Criteria
October 28, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B0401005
- 2009-012179-82 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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