--- title: "Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil" nct_id: NCT01712074 overall_status: TERMINATED phase: PHASE2 sponsor: Pfizer study_type: INTERVENTIONAL primary_condition: "Alzheimer's Disease" countries: United States, Canada, Chile, France, Germany, Spain, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01712074.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01712074" ct_last_update_post_date: 2017-03-20 last_seen_at: "2026-05-12T06:05:23.450Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT01712074](https://clinicaltrials.gov/study/NCT01712074) ## Key Facts - **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. - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 186 - **Lead Sponsor:** Pfizer - **Conditions:** Alzheimer's Disease - **Start Date:** 2012-11 - **Completion Date:** 2015-09 - **CT.gov Last Update:** 2017-03-20 ## 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. ## Eligibility - **Minimum age:** 60 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **30 mg QD of PF-05212377** (EXPERIMENTAL) - **Placebo** (PLACEBO_COMPARATOR) ## Interventions - **PF-05212377 (SAM-760)** (DRUG) — 30 mg QD of PF-05212377 (SAM-760) - **Placebo** (OTHER) — Placebo QD ## Primary Outcomes - **Change From Baseline in ADAS-cog13 Total Score at Week 16** _(time frame: Baseline and 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 Outcomes - **Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)** _(time frame: Baseline and Week 16)_ ## Locations (60) - ATP Clinical Research, Inc, Costa Mesa, California, United States - Sun Valley Research Center, Imperial, California, United States - Desert Valley Research, Rancho Mirage, California, United States - RAA - Apex Aquisition, LLC, Santa Ana, California, United States - Geriatric and Adult Psychiatry LLC, Hamden, Connecticut, United States - Yale University, New Haven, Connecticut, United States - Yale-New Haven Hospital, Temple Radiology, New Haven, Connecticut, United States - Yale University School of Medicine, MRI Research Center (MRI), New Haven, Connecticut, United States - Diagnostic Centers of America, Boynton Beach, Florida, United States - Meridien Research, Brooksville, Florida, United States - Quantum Laboratories, Deerfield Beach, Florida, United States - Brain Matters Research Inc, Delray Beach, Florida, United States - MD Clinical, Hallandale, Florida, United States - Compass Research LLC-North Clinic, Leesburg, Florida, United States - Medical Research Group of Central Florida, Orange City, Florida, United States - Premiere Research Institute, West Palm Beach, Florida, United States - Institute for Advanced Medical Research, Alpharetta, Georgia, United States - Atlanta Center for Medical Research, Atlanta, Georgia, United States - Columbus Research & Wellness Institute, Inc., Columbus, Georgia, United States - Lake Charles Clinical Trials, Lake Charles, Louisiana, United States - Michigan State University, East Lansing, Michigan, United States - Metro Imaging (Imaging only), Creve Coeur, Missouri, United States - Millennium Psychiatric Associates, LLC, Creve Coeur, Missouri, United States - Eastside Comprehensive Medical Center, LLC, New York, New York, United States - University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center, Rochester, New York, United States - University of Rochester Medical Center (MRI Imaging Only), Rochester, New York, United States - Behavioral Medical Research of Staten Island, Staten Island, New York, United States - The Ohio State University (administrative offices only), Columbus, Ohio, United States - The Ohio State University - 2050, Columbus, Ohio, United States - Keystone Clinical Studies, LLC, Norristown, Pennsylvania, 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 - Neurology Clinic, P.C., Cordova, Tennessee, United States - Senior Adults Speciality Research Inc., Austin, Texas, United States - Grayline Clinical Drug Trials, Wichita Falls, Texas, United States - Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic, Bennington, Vermont, United States - Dean Foundation for Health, Research and Education, Middleton, Wisconsin, United States - Cary J. Kohlenberg, MD, dba, IPC Research, Waukesha, Wisconsin, United States - Merrill Hills Manor, Waukesha, Wisconsin, United States - True North Clinical Research Halifax, Inc., Halifax, Nova Scotia, Canada - Chatham-kent Clinical Trials Research Centre, Chatham, Ontario, Canada - Chatham-Kent Clinical Trials Research Centre, Chatham, Ontario, Canada - Recherches Neuro-Hippocampe Inc., Gatineau, Quebec, Canada - Psicomed Estudios Medicos CIA. LTDA, Antofagasta, Antofagasta, Chile - Biomedica Research Group, Santiago, Santiago Metropolitan, Chile - Especialidades Medicas L Y S, Santiago, Santiago Metropolitan, Chile - Espace Sante 2, La Seyne-sur-Mer, France - 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, Nuremberg, Germany - Hospital General Universitario De Elche, Elche, Alicante, Spain - Hospital de Cantoblanco, Madrid, Madrid, Spain - 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 - Covance Laboratories, Switzerland, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.atp clinical research, inc|costa mesa|california|united states` — added _(2026-05-12)_ - `locations.sun valley research center|imperial|california|united states` — added _(2026-05-12)_ - `locations.desert valley research|rancho mirage|california|united states` — added _(2026-05-12)_ - `locations.raa - apex aquisition, llc|santa ana|california|united states` — added _(2026-05-12)_ - `locations.geriatric and adult psychiatry llc|hamden|connecticut|united states` — added _(2026-05-12)_ - `locations.yale university|new haven|connecticut|united states` — added _(2026-05-12)_ - `locations.yale-new haven hospital, temple radiology|new haven|connecticut|united states` — added _(2026-05-12)_ - `locations.yale university school of medicine, mri research center (mri)|new haven|connecticut|united states` — added _(2026-05-12)_ - `locations.diagnostic centers of america|boynton beach|florida|united states` — added _(2026-05-12)_ - `locations.meridien research|brooksville|florida|united states` — added _(2026-05-12)_ - `locations.quantum laboratories|deerfield beach|florida|united states` — added _(2026-05-12)_ - `locations.brain matters research inc|delray beach|florida|united states` — added _(2026-05-12)_ - `locations.md clinical|hallandale|florida|united states` — added _(2026-05-12)_ - `locations.compass research llc-north clinic|leesburg|florida|united states` — added _(2026-05-12)_ - `locations.medical research group of central florida|orange city|florida|united states` — added _(2026-05-12)_ - `locations.premiere research institute|west palm beach|florida|united states` — added _(2026-05-12)_ - `locations.institute for advanced medical research|alpharetta|georgia|united states` — added _(2026-05-12)_ - `locations.atlanta center for medical research|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.columbus research & wellness institute, inc.|columbus|georgia|united states` — added _(2026-05-12)_ - `locations.lake charles clinical trials|lake charles|louisiana|united states` — added _(2026-05-12)_ - `locations.michigan state university|east lansing|michigan|united states` — added _(2026-05-12)_ - `locations.metro imaging (imaging only)|creve coeur|missouri|united states` — added _(2026-05-12)_ - `locations.millennium psychiatric associates, llc|creve coeur|missouri|united states` — added _(2026-05-12)_ - `locations.eastside comprehensive medical center, llc|new york|new york|united states` — added _(2026-05-12)_ - `locations.university of rochester medical center ad-care program | university of rochester medical center|rochester|new york|united states` — added _(2026-05-12)_ - `locations.university of rochester medical center (mri imaging only)|rochester|new york|united states` — added _(2026-05-12)_ - `locations.behavioral medical research of staten island|staten island|new york|united states` — added _(2026-05-12)_ - `locations.the ohio state university (administrative offices only)|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.the ohio state university - 2050|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.keystone clinical studies, llc|norristown|pennsylvania|united states` — added _(2026-05-12)_ - `locations.roper hospital (imaging only)|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.roper st. francis healthcare|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.roper st. francis pharmacy (ip shipment/storage)|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.neurology clinic, p.c.|cordova|tennessee|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01712074.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01712074* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*