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

NCT01712074 | Terminated Phase 2 Results DMC

• 2 other identifiers: B20810112014-000830-42
• Study Type: interventional
• Target: 186
• Locations: 7 countries
• Sites: 60

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.

Conditions

Alzheimer's Disease

Keywords

Randomized; Double Blind; Safety and Efficacy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 16

Secondary Outcomes (1)

• Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)

  Baseline and Week 16

Other Outcomes (22)

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation

  Week 4 to Week 18

• Proportion of Participants With Laboratory Abnormalities of Potential Clinical Concern During Double Blind Period

  Week 4 to Week 16

• Selected ECG Change From Baseline - PR Interval at Week 6 (Visit 3)

  Baseline and Week 6

Study Arms (2)

30 mg QD of PF-05212377

EXPERIMENTAL

Drug: PF-05212377 (SAM-760)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

PF-05212377 (SAM-760) DRUG

30 mg QD of PF-05212377 (SAM-760)

30 mg QD of PF-05212377

Placebo OTHER

Placebo QD

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (60)

ATP Clinical Research, Inc

Costa Mesa, California, 92626, United States

Location

Sun Valley Research Center

Imperial, California, 92251, United States

Location

Desert Valley Research

Rancho Mirage, California, 92270, United States

Location

RAA - Apex Aquisition, LLC

Santa Ana, California, 92705, United States

Location

Geriatric and Adult Psychiatry LLC

Hamden, Connecticut, 06518, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Yale-New Haven Hospital, Temple Radiology

New Haven, Connecticut, 06510, United States

Location

Yale University School of Medicine, MRI Research Center (MRI)

New Haven, Connecticut, 06520, United States

Location

Diagnostic Centers of America

Boynton Beach, Florida, 33437, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Quantum Laboratories

Deerfield Beach, Florida, 33064, United States

Location

Brain Matters Research Inc

Delray Beach, Florida, 33445, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Compass Research LLC-North Clinic

Leesburg, Florida, 34748, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Institute for Advanced Medical Research

Alpharetta, Georgia, 30005, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Columbus Research & Wellness Institute, Inc.

Columbus, Georgia, 31904, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Metro Imaging (Imaging only)

Creve Coeur, Missouri, 63141, United States

Location

Millennium Psychiatric Associates, LLC

Creve Coeur, Missouri, 63141, United States

Location

Eastside Comprehensive Medical Center, LLC

New York, New York, 10021, United States

Location

University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

University of Rochester Medical Center (MRI Imaging Only)

Rochester, New York, 14642, United States

Location

Behavioral Medical Research of Staten Island

Staten Island, New York, 10305, United States

Location

The Ohio State University (administrative offices only)

Columbus, Ohio, 43212, United States

Location

The Ohio State University - 2050

Columbus, Ohio, 43221, United States

Location

Keystone Clinical Studies, LLC

Norristown, Pennsylvania, 19403, United States

Location

Roper Hospital (Imaging Only)

Charleston, South Carolina, 29401, United States

Location

Roper St. Francis Healthcare

Charleston, South Carolina, 29401, United States

Location

Roper St. Francis Pharmacy (IP Shipment/Storage)

Charleston, South Carolina, 29401, United States

Location

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

Location

Senior Adults Speciality Research Inc.

Austin, Texas, 78757, United States

Location

Grayline Clinical Drug Trials

Wichita Falls, Texas, 76309, United States

Location

Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic

Bennington, Vermont, 05201, United States

Location

Dean Foundation for Health, Research and Education

Middleton, Wisconsin, 53562, United States

Location

Cary J. Kohlenberg, MD, dba, IPC Research

Waukesha, Wisconsin, 53188, United States

Location

Merrill Hills Manor

Waukesha, Wisconsin, 53226, United States

Location

True North Clinical Research Halifax, Inc.

Halifax, Nova Scotia, B3S 1M7, Canada

Location

Chatham-kent Clinical Trials Research Centre

Chatham, Ontario, N7L 1C1, Canada

Location

Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, N7M 5L9, Canada

Location

Recherches Neuro-Hippocampe Inc.

Gatineau, Quebec, J8T 8J1, Canada

Location

Psicomed Estudios Medicos CIA. LTDA

Antofagasta, Antofagasta, 1270244, Chile

Location

Biomedica Research Group

Santiago, Santiago Metropolitan, 7500710, Chile

Location

Especialidades Medicas L Y S

Santiago, Santiago Metropolitan, 7560356, Chile

Location

Espace Sante 2

La Seyne-sur-Mer, 83500, France

Location

Dr. med. Volker Schumann, Arzt fuer Nervenheilkunde

Berlin, 10245, Germany

Location

Praxis Dr. Franz- Arztehaus am KEH mit Epilepsie-Zentrum

Berlin, 10365, Germany

Location

Praxis Dr. sc. med. Alexander Schulze

Berlin, 13156, Germany

Location

Arzneimittelforschung Leipzig Gmbh

Leipzig, 04107, Germany

Location

Praxis fuer Neurologie / Psychiatrie Prof. Dr. Steinwachs

Nuremberg, 90402, Germany

Location

Hospital General Universitario De Elche

Elche, Alicante, 03203, Spain

Location

Hospital de Cantoblanco

Madrid, Madrid, 28049, Spain

Location

The Research Institute for the Care of Older People Centre

Bath, BA1 3NG, United Kingdom

Location

Fulbourn Hospital

Cambridge, CB21 5EF, United Kingdom

Location

Surrey and Borders Partnership NHS Foundation Trust

Chertsey, KT16 0AE, United Kingdom

Location

Berrywood Hospital

Northampton, NN5 6UD, United Kingdom

Location

Covance Laboratories

Switzerland, 1217, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29622037 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

SAM-760

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer
• Organization: Pfizer

ClinicalTrials.gov_Inquiries@pfizer.com

1-8007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 23, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 20, 2017
• Results First Posted: March 20, 2017

Record last verified: 2017-01

Locations

GB (5); ES (2); DE (5); US (40); CA (4); CL (3); FR (1)