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Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-05212377 (SAM-760)
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Randomized, Double Blind, Safety and Efficacy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of probable AD with supportive brain imaging documentation
  • Have existing neuropsychiatric symptoms as defined by a score equal or greater than 10 on the NPI at screening, arising from item scores equal or greater than 2 (frequency X severity) on at least 2 domains.
  • Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no intent to change such for the duration of the study.

Exclusion Criteria:

  • Demonstrate extreme agitation, physical aggression or violence to themselves, their caregiver, or others, and/or an inability to complete the ADAS-cog assessment at Screening.
  • Have major structural brain disease other than Alzheimer's Disease
  • Other severe acute or chronical medical or psychiatric condition or laboratory abnormality

Sites / Locations

  • ATP Clinical Research, Inc
  • Sun Valley Research Center
  • Desert Valley Research
  • RAA - Apex Aquisition, LLC
  • Geriatric and Adult Psychiatry LLC
  • Yale University
  • Yale-New Haven Hospital, Temple Radiology
  • Yale University School of Medicine, MRI Research Center (MRI)
  • Diagnostic Centers of America
  • Meridien Research
  • Quantum Laboratories
  • Brain Matters Research Inc
  • MD Clinical
  • Compass Research LLC-North Clinic
  • Medical Research Group of Central Florida
  • Premiere Research Institute
  • Institute for Advanced Medical Research
  • Atlanta Center for Medical Research
  • Columbus Research & Wellness Institute, Inc.
  • Lake Charles Clinical Trials
  • Michigan State University
  • Metro Imaging (Imaging only)
  • Millennium Psychiatric Associates, LLC
  • Eastside Comprehensive Medical Center, LLC
  • University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center
  • University of Rochester Medical Center (MRI Imaging Only)
  • Behavioral Medical Research of Staten Island
  • The Ohio State University (administrative offices only)
  • The Ohio State University - 2050
  • Keystone Clinical Studies, LLC
  • Roper Hospital (Imaging Only)
  • Roper St. Francis Healthcare
  • Roper St. Francis Pharmacy (IP Shipment/Storage)
  • Neurology Clinic, P.C.
  • Senior Adults Speciality Research Inc.
  • Grayline Clinical Drug Trials
  • Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic
  • Dean Foundation for Health, Research and Education
  • Cary J. Kohlenberg, MD, dba, IPC Research
  • Merrill Hills Manor
  • True North Clinical Research Halifax, Inc.
  • Chatham-kent Clinical Trials Research Centre
  • Chatham-Kent Clinical Trials Research Centre
  • Recherches Neuro-Hippocampe Inc.
  • Psicomed Estudios Medicos CIA. LTDA
  • Biomedica Research Group
  • Especialidades Medicas L Y S
  • Espace Sante 2
  • Dr. med. Volker Schumann, Arzt fuer Nervenheilkunde
  • Praxis Dr. Franz- Arztehaus am KEH mit Epilepsie-Zentrum
  • Praxis Dr. sc. med. Alexander Schulze
  • Arzneimittelforschung Leipzig Gmbh
  • Praxis fuer Neurologie / Psychiatrie Prof. Dr. Steinwachs
  • Hospital General Universitario De Elche
  • Hospital de Cantoblanco
  • The Research Institute for the Care of Older People Centre
  • Fulbourn Hospital
  • Surrey and Borders Partnership NHS Foundation Trust
  • Berrywood Hospital
  • Covance Laboratories

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

30 mg QD of PF-05212377

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in ADAS-cog13 Total Score at Week 16
ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.

Secondary Outcome Measures

Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)
The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.

Full Information

First Posted
October 19, 2012
Last Updated
January 30, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01712074
Brief Title
Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil
Official Title
A Randomized, 18-week, Placebo-controlled, Double-blind, Parallel Group Study Of The Safety And Efficacy Of Pf-05212377 (Sam-760) In Subjects With Mild-to-moderate Alzheimer's Disease With Existing Neuropsychiatric Symptoms On A Stable Daily Dose Of Donepezil
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated October 23, 2015 as pre-specified, interim analysis futility criteria were met. The termination was not due to safety concerns.
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (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
This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Randomized, Double Blind, Safety and Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30 mg QD of PF-05212377
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-05212377 (SAM-760)
Intervention Description
30 mg QD of PF-05212377 (SAM-760)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo QD
Primary Outcome Measure Information:
Title
Change From Baseline in ADAS-cog13 Total Score at Week 16
Description
ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)
Description
The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.
Time Frame
Baseline and Week 16
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
Description
Proportion of participants with TEAEs leading to discontinuation over the 12-week double blind treatment period and washout. Adverse events (AEs) occurring following start of treatment or increasing in severity were counted as treatment emergent
Time Frame
Week 4 to Week 18
Title
Proportion of Participants With Laboratory Abnormalities of Potential Clinical Concern During Double Blind Period
Description
Proportion (%) of participants with laboratory abnormalities (without regard to baseline abnormalities) of potential clinical concern over the 12-week double blind treatment period. The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (only at screening or needed: urine drug screen, thyroid panel, Vitamin B12, methylmalonic acid, folate and Hemoglobin A1).
Time Frame
Week 4 to Week 16
Title
Selected ECG Change From Baseline - PR Interval at Week 6 (Visit 3)
Description
The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).
Time Frame
Baseline and Week 6
Title
Selected ECG Change From Baseline - PR Interval at Week 10 (Visit 4)
Description
The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).
Time Frame
Baseline and Week 10
Title
Selected ECG Change From Baseline - PR Interval at Week 16/Early Termination (Visit 5)
Description
The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).
Time Frame
Baseline and Week 16/Early Termination
Title
Percentage of Participant With PR Interval Abnormalities of Potential Clinical Concern
Description
Proportion (%) of participants with PR Interval abnormalities meeting categorical criteria over the 12 week double blind treatment period. The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline PR absolute value>=300 msec , a PR increase of >=25% (for participants with a baseline value>=200 msec), or with an increase >=50% (for participants with a baseline value<200 msec) were counted.
Time Frame
Week 4 to Week 16
Title
Selected ECG Change From Baseline - QRS Complex at Week 6 (Visit 3)
Description
The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.
Time Frame
Baseline and Week 6
Title
Selected ECG Change From Baseline - QRS Complex at Week 10 (Visit 4)
Description
The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.
Time Frame
Baseline and Week 10
Title
Selected ECG Change From Baseline - QRS Complex at Week 16/Early Termination (Visit 5)
Description
The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.
Time Frame
Baseline and Week 16/Early Termination
Title
Proportion of Participants With QRS Complex Abnormalities of Potential Clinical Concern
Description
Proportion (%) of participants with QRS Complex abnormalities meeting categorical criteria over the 12 week double blind treatment period. The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline QRS complex absolute value>=100 msec , a QRS complex increase of >=25% (for participants with a baseline value>=100 msec), or with an increase >=50% (for participants with a baseline value<100 msec) were counted.
Time Frame
Week 4 to Week 16
Title
Selected ECG Change From Baseline - QTcF Interval at Week 6 (Visit 3)
Description
The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.
Time Frame
Baseline and Week 6
Title
Selected ECG Change From Baseline - QTcF Interval at Week 10 (Visit 4)
Description
The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.
Time Frame
Baseline and Week 10
Title
Selected ECG Change From Baseline - QTcF Interval at Week 16/Early Termination (Visit 5)
Description
The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.
Time Frame
Baseline and Week 16/Early Termination
Title
Proportion of Participants With QTcF Interval Abnormalities of Potential Clinical Concern
Description
Proportion (%) of participants with QTcF Interval abnormalities meeting categorical criteria over the 12-week double blind treatment period. The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula. Participants with a post-baseline QTcF absolute value of 450 - <480, 480 - <500, or >=500 mec, or with a post-baseline QTcF increase of 30 - <60 or >=60 msec were counted.
Time Frame
Week 4 to Week 16
Title
Blood Pressure (BP) Changes From Baseline - Week 6 (Visit 3)
Description
The BP changes from baseline at Week 6 (Visit 3) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.
Time Frame
Baseline and Week 6
Title
Pulse Rate Changes From Baseline - Week 6 (Visit 3)
Description
The pulse rate changes from baseline at Week 6 (Visit 3) including supine pulse rate, and standing pulse rate.
Time Frame
Baseline and Week 6
Title
BP Changes From Baseline - Week 10 (Visit 4)
Description
The BP changes from baseline at Week 10 (Visit 4) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.
Time Frame
Baseline and Week 10
Title
Pulse Rate Changes From Baseline - Week 10 (Visit 4)
Description
The pulse rate changes from baseline at Week 10 (Visit 4) including supine pulse rate, and standing pulse rate.
Time Frame
Baseline and Week 10
Title
BP Changes From Baseline - Week 16/Early Termination (Visit 5)
Description
The BP changes from baseline at Week 16/Early Termination (Visit 5) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.
Time Frame
Baseline and Week 16/Early Termination
Title
Pulse Rate Changes From Baseline - Week 16/Early Termination (Visit 5)
Description
The pulse rate changes from baseline at Week 16/Early Termination (Visit 5) including supine pulse rate, and standing pulse rate.
Time Frame
Baseline and Week 16/Early Termination
Title
Proportion of Participants With Post-Baseline Vital Signs Abnormalities of Potential Clinical Concern
Description
Proportion (%) of participants with vital signs abnormalities (absolute and change from baseline) meeting categorical criteria over the 12-week double blind treatment period were counted. Vital signs data included blood pressure (BP) and pulse rate.
Time Frame
Week 4 to Week 16
Title
Participants in Each Category of C-CASA Mapped From the C-SSRS Responses
Description
Participants in each category of the Columbia Classification Algorithm of Suicide Assessment (C-CASA) mapped from the Columbia-Suicide Severity Rating Scale (C-SSRS) responses were reported. C-CASA Event Code: <1> Completed suicide; <2> Suicide attempt; <3> Preparatory acts towards imminent suicidal behavior; <4> Suicidal Ideation; <7> Self-injurious behavior, no suicidal intent. The suicidality assessments were performed at Screening, Week 0 (Visit 1), Week 4 (Visit 2), Week 6, (Visit 3), Week 10 (Visit 4), Week 16 (Visit 5), and Week 18 (Visit 6). Only participants falling any category of C-CASA events were listed below.
Time Frame
From Screening to Week 18/Early Termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of probable AD with supportive brain imaging documentation Have existing neuropsychiatric symptoms as defined by a score equal or greater than 10 on the NPI at screening, arising from item scores equal or greater than 2 (frequency X severity) on at least 2 domains. Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no intent to change such for the duration of the study. Exclusion Criteria: Demonstrate extreme agitation, physical aggression or violence to themselves, their caregiver, or others, and/or an inability to complete the ADAS-cog assessment at Screening. Have major structural brain disease other than Alzheimer's Disease Other severe acute or chronical medical or psychiatric condition or laboratory abnormality
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
ATP Clinical Research, Inc
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Sun Valley Research Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Desert Valley Research
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
RAA - Apex Aquisition, LLC
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Geriatric and Adult Psychiatry LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale-New Haven Hospital, Temple Radiology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School of Medicine, MRI Research Center (MRI)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Diagnostic Centers of America
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Quantum Laboratories
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Brain Matters Research Inc
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
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-North Clinic
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Institute for Advanced Medical Research
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Columbus Research & Wellness Institute, Inc.
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Metro Imaging (Imaging only)
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Millennium Psychiatric Associates, LLC
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Eastside Comprehensive Medical Center, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University of Rochester Medical Center (MRI Imaging Only)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
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
The Ohio State University (administrative offices only)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
The Ohio State University - 2050
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Keystone Clinical Studies, LLC
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
Roper Hospital (Imaging Only)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Roper St. Francis Healthcare
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Roper St. Francis Pharmacy (IP Shipment/Storage)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Neurology Clinic, P.C.
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Senior Adults Speciality Research Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Dean Foundation for Health, Research and Education
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Cary J. Kohlenberg, MD, dba, IPC Research
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Merrill Hills Manor
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
True North Clinical Research Halifax, Inc.
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1M7
Country
Canada
Facility Name
Chatham-kent Clinical Trials Research Centre
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L 1C1
Country
Canada
Facility Name
Chatham-Kent Clinical Trials Research Centre
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7M 5L9
Country
Canada
Facility Name
Recherches Neuro-Hippocampe Inc.
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8T 8J1
Country
Canada
Facility Name
Psicomed Estudios Medicos CIA. LTDA
City
Antofagasta
State/Province
Ii Region
ZIP/Postal Code
1270244
Country
Chile
Facility Name
Biomedica Research Group
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Especialidades Medicas L Y S
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7560356
Country
Chile
Facility Name
Espace Sante 2
City
La Seyne Sur Mer
ZIP/Postal Code
83500
Country
France
Facility Name
Dr. med. Volker Schumann, Arzt fuer Nervenheilkunde
City
Berlin
ZIP/Postal Code
10245
Country
Germany
Facility Name
Praxis Dr. Franz- Arztehaus am KEH mit Epilepsie-Zentrum
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Praxis Dr. sc. med. Alexander Schulze
City
Berlin
ZIP/Postal Code
13156
Country
Germany
Facility Name
Arzneimittelforschung Leipzig Gmbh
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Praxis fuer Neurologie / Psychiatrie Prof. Dr. Steinwachs
City
Nuernberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Hospital General Universitario De Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital de Cantoblanco
City
Madrid
ZIP/Postal Code
28049
Country
Spain
Facility Name
The Research Institute for the Care of Older People Centre
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Fulbourn Hospital
City
Cambridge
ZIP/Postal Code
CB21 5EF
Country
United Kingdom
Facility Name
Surrey and Borders Partnership NHS Foundation Trust
City
Chertsey
ZIP/Postal Code
KT16 0AE
Country
United Kingdom
Facility Name
Berrywood Hospital
City
Northampton
ZIP/Postal Code
NN5 6UD
Country
United Kingdom
Facility Name
Covance Laboratories
City
Switzerland
ZIP/Postal Code
1217
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29622037
Citation
Fullerton T, Binneman B, David W, Delnomdedieu M, Kupiec J, Lockwood P, Mancuso J, Miceli J, Bell J. A Phase 2 clinical trial of PF-05212377 (SAM-760) in subjects with mild to moderate Alzheimer's disease with existing neuropsychiatric symptoms on a stable daily dose of donepezil. Alzheimers Res Ther. 2018 Apr 5;10(1):38. doi: 10.1186/s13195-018-0368-9.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2081011&StudyName=Study%20Evaluating%20TheSafety%20And%20Efficacy%20Of%20PF-05212377%20Or%20Placebo%20In%20Subjects%20With%20Alzheimer%27s%20Disease%20With%20Existing%20Neuropsychiatric%20Symp
Description
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Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil

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