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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01712074
• Other study ID #: B2081011
• Secondary ID: 2014-000830-42
• Status: Terminated
• Phase: Phase 2
• First received: October 19, 2012
• Last updated: January 29, 2016
• Start date: November 2012
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 186
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• PF-05212377 (SAM-760)
30 mg QD of PF-05212377 (SAM-760)

Other:
• Placebo
Placebo QD

Locations

Country	Name	City	State
Canada	Chatham-Kent Clinical Trials Research Centre	Chatham	Ontario
Canada	Recherches Neuro-Hippocampe Inc.	Gatineau	Quebec
Canada	True North Clinical Research Halifax, Inc.	Halifax	Nova Scotia
Chile	Psicomed Estudios Medicos CIA. LTDA	Antofagasta	II Region
Chile	Biomedica Research Group	Santiago	Region Metropolitana
Chile	Especialidades Medicas Lys	Santiago	Metropolitana
France	Espace Sante 2	La Seyne Sur Mer
Germany	Dr. med. Volker Schumann, Arzt fuer Nervenheilkunde	Berlin
Germany	Praxis Dr. Franz- Arztehaus am KEH mit Epilepsie-Zentrum	Berlin
Germany	Praxis Dr. sc. med. Alexander Schulze	Berlin
Germany	Arzneimittelforschung Leipzig Gmbh	Leipzig
Germany	Praxis fuer Neurologie / Psychiatrie Prof. Dr. Steinwachs	Nuernberg
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital de Cantoblanco	Madrid
United Kingdom	The Research Institute for the Care of Older People Centre	Bath
United Kingdom	Fulbourn Hospital	Cambridge
United Kingdom	Surrey and Borders Partnership NHS Foundation Trust	Chertsey
United Kingdom	Berrywood Hospital	Northampton
United Kingdom	NHS Foundation Trust-Surrey and Borders Partnership - Kingsfield Resource Centre	Redhill
United Kingdom	Covance Laboratories	Switzerland
United States	Institute for Advanced Medical Research	Alpharetta	Georgia
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Central Park Imaging Center	Austin	Texas
United States	Clinical Pathology Laboratories, Inc	Austin	Texas
United States	Senior Adults Speciality Research Inc.	Austin	Texas
United States	Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic	Bennington	Vermont
United States	Diagnostic Centers of America	Boynton Beach	Florida
United States	Meridien Research	Brooksville	Florida
United States	Roper Hospital (Imaging Only)	Charleston	South Carolina
United States	Roper St. Francis Healthcare	Charleston	South Carolina
United States	Roper St. Francis Pharmacy (IP Shipment/Storage)	Charleston	South Carolina
United States	Columbus Research & Wellness Institute, Inc.	Columbus	Georgia
United States	The Ohio State University - 2006	Columbus	Ohio
United States	Neurology Clinic, P.C.	Cordova	Tennessee
United States	ATP Clinical Research, Inc	Costa Mesa	California
United States	Metro Imaging (Imaging only)	Creve Coeur	Missouri
United States	Millennium Psychiatric Associates, LLC	Creve Coeur	Missouri
United States	Quantum Laboratories	Deerfield Beach	Florida
United States	Brain Matters Research Inc	Delray Beach	Florida
United States	Michigan State University	East Lansing	Michigan
United States	Michigan State University Department of Radiology (MRI) or (CT)	East Lansing	Michigan
United States	MD Clinical	Hallandale Beach	Florida
United States	Geriatric and Adult Psychiatry LLC	Hamden	Connecticut
United States	Sun Valley Research Center	Imperial	California
United States	Covance Central Laboratory Services, Inc	Indianapolis	Indiana
United States	Covance Central Laboratory Services, Inc.	Indianapolis	Indiana
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Sparrow Regional Laboratories	Lansing	Michigan
United States	Compass Research LLC-North Clinic	Leesburg	Florida
United States	Dean Foundation for Health, Research and Education	Middleton	Wisconsin
United States	San Camillo	Milwaukee	Wisconsin
United States	Yale University	New Haven	Connecticut
United States	Yale University School of Medicine, MRI Research Center (MRI)	New Haven	Connecticut
United States	Yale-New Haven Hospital, Temple Radiology	New Haven	Connecticut
United States	Eastside Comprehensive Medical Center, LLC	New York	New York
United States	Keystone Clinical Studies, LLC	Norristown	Pennsylvania
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	eResearch Technology, Inc.	Philadelphia	Pennsylvania
United States	eResearch Technology, Incorporated	Philadelphia	Pennsylvania
United States	eResearch Technology, Incorporated	Philadlephia	Wisconsin
United States	Desert Valley Research	Rancho Mirage	California
United States	Imaging Sciences - MRI University of Rochester Medical Center	Rochester	New York
United States	University of Rochester Medical Center AD-CARE Program	Rochester	New York
United States	RAA - Apex Acquisition	Santa Ana	California
United States	Behavioral Medical Research of Staten Island	Staten Island	New York
United States	Cary J. Kohlenberg, MD, SC, dba, IPC Research	Waukesha	Wisconsin
United States	Merrill Hills Manor	Waukesha	Wisconsin
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Chile,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline (Week 4) to 12 weeks after the start of double-blind study medication on the ADAS-cog13 total score (Week 16)	ADAS-cog13 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 scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.	Week 16	No
Secondary	Change from baseline (Week 4) to 12 weeks after the start of double-blind study medication on the NPI total score (Week 16).	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 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.	Week 16	No

External Links

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