Agitation in Patients With Dementia of the Alzheimer's Type Clinical Trial
Official title:
A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.
| Status | Recruiting |
| Enrollment | 1200 |
| Est. completion date | January 30, 2025 |
| Est. primary completion date | January 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 90 Years |
| Eligibility | Inclusion Criteria: - Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.) - Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria - Either out-patients or residents of an assisted-living facility or a skilled nursing home - Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline - Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation - Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of = 4 (moderately ill) at screening and baseline - Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline Exclusion Criteria: - Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease) - Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator - Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Center for Mental Health - Ruse | Ruse | |
| Bulgaria | Medical Center Sveti Naum Site #707 | Sofia | |
| Bulgaria | Mental Health Centre Prof. Nikola Shipkovenski Site #713 | Sofia | |
| Bulgaria | University Multiprofile Hospital for Active Treatment Alexandrovska Site #704 | Sofia | |
| Bulgaria | Vrach and Sv. Sv. Kuzma and Damian Site #710 | Sofia | |
| Bulgaria | Medical Center Mladost-M | Varna | |
| Bulgaria | Medica Plus Medical Center | Veliko Tarnovo | |
| Canada | Dr. Alexander McIntyre Inc. | Penticton | |
| Czechia | Fakultni Nemocnice u sv. Anny v Brne Site #722 | Brno | |
| Czechia | Fakultní Nemocnice Hradec Králové Site #724 | Hradec Kralové | |
| Czechia | NeuropsychiatrieHK Site #729 | Hradec Kralové | |
| Czechia | Brain-Soultherapy | Kladno | |
| Czechia | Námestí národního odboje 692 Site #723 | Kutna Hora | |
| Czechia | A-Shine s.r.o. Site #731 | Plzen | |
| Czechia | AD71 | Praha | |
| Czechia | Clintrial | Praha | |
| Czechia | Neurologicka Ambulance - Forbeli | Praha | |
| Czechia | Neuropsychiatrie Site #726 | Praha | |
| Czechia | Vestra Clinics | Rychnov nad Knežnou | |
| France | Centre Hospitalier Universitaire Dijon Bourgogn Site #536 | Dijon Cedex | |
| France | Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord Site #535 | Saint-Etienne | Auvergne-Rhone-Alpes |
| France | Centre Hospitalier Universitaire Toulouse - Casselardit Ancely Site #533 | Toulouse | |
| Hungary | Dr. Kenessey Albert Kórház-Rendelointézet | Balassagyarmat | |
| Hungary | Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly Site #586 | Budapest | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Hungary | Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz | Debrecen | |
| Hungary | Dr. Mathe es Tarsa Beteti Tarsasag Site #593 | Kalocsa | |
| Hungary | PsychoTech Clinical Research Site# 580 | Pécs | |
| Italy | Azienda Ospedaliera Sant'Andrea Site #606 | Roma | |
| Italy | Fondazione Policlinico Tor Vergata Site #609 | Roma | |
| Italy | Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico | Roma | |
| Poland | Ksiedza Hugona Kollataja 9 | Bydgoszcz | |
| Poland | Care Clinic Clinical Research Site #750 | Katowice | |
| Poland | Wielospecjalistyczna Poradnia Lekarska Synapsis Site #741 | Katowice | |
| Poland | Krakowska Akademia Neurologii Site #740 | Kraków | |
| Poland | Malopolskie Centrum Medyczne Site #747 | Kraków | |
| Poland | Medycyna Milorzab Site #743 | Lodz | |
| Poland | Solumed Centrum Medyczne Site #753 | Poznan | |
| Poland | Centrum Medyczne Euromedis | Szczecin | |
| Poland | Centrum Medyczne NeuroProtect Site #742 | Warszawa | |
| Poland | ClinHouse Centrum Medyczne | Zabrze | |
| South Africa | ACF Neurological Services | Cape Town | |
| South Africa | Cape Trial Centre | Cape Town | |
| South Africa | Flexivest Fourteen Research Centre | Cape Town | |
| South Africa | Apollo Clinical Research Site #623 | Johannesburg | |
| South Africa | Medical and Dental Centre | Rosebank | |
| Spain | Accellacare Alcobendas | Alcobendas | |
| Spain | Fundació ACE | Barcelona | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital General Universitario de Elche | Elche | |
| Spain | Hospital Universitario 12 de Octubre Site #657 | Madrid | |
| Spain | Hospital Universitario de Salamanca | Salamanca | |
| Spain | Hospital Universitario Virgen Macarena Site #649 | Sevilla | |
| Spain | Complejo Asistencial de Zamora Hospital Virgen de la Concha | Zamora | |
| Spain | Hospital Viamed Montecanal Site #643 | Zaragoza | |
| United States | Daystar Clinical Research Inc | Akron | Ohio |
| United States | Neurology and Neuroscience Associates, Inc. | Akron | Ohio |
| United States | Neurology of Central Florida Rsch Ctr Site #803 | Altamonte Springs | Florida |
| United States | Dent Neurologic Institute | Amherst | New York |
| United States | Advanced Research Center, Inc. Site #835 | Anaheim | California |
| United States | Emory Brain Health Center | Atlanta | Georgia |
| United States | NeuroTrials Research Inc | Atlanta | Georgia |
| United States | JEM Research Institute | Atlantis | Florida |
| United States | Negron Research Services / Humanity Clinical Research Site# 766 | Aventura | Florida |
| United States | Insight Clinical Trials, LLC Site #570 | Beachwood | Ohio |
| United States | Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania |
| United States | Bedford VA Hospital | Bedford | Massachusetts |
| United States | Insight Neuroscience, LLC | Bellevue | Ohio |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic | Bennington | Vermont |
| United States | Neurology Offices of South Florida | Boca Raton | Florida |
| United States | SFM Clinical Research, LLC Site #563 | Boca Raton | Florida |
| United States | Bradenton Research Center Site #834 | Bradenton | Florida |
| United States | Alzheimer Disease Center Site #804 | Braintree | Massachusetts |
| United States | Clinical Research of Brandon | Brandon | Florida |
| United States | Clinical Research Of Brandon, LLC Site #838 | Brandon | Florida |
| United States | Brooklyn Medical Institute | Brooklyn | New York |
| United States | Integrative Clinical Trials LLC #1 | Brooklyn | New York |
| United States | Integrative Clinical Trials LLC #2 | Brooklyn | New York |
| United States | Meridien Research | Brooksville | Florida |
| United States | Onyx Clinical Research, LLC | Caro | Michigan |
| United States | Valley Medical Research | Centerville | Ohio |
| United States | Valley Medical Research Site #788 | Centerville | Ohio |
| United States | Brain and Spine Center | Chandler | Arizona |
| United States | MD First Research, LLC | Chandler | Arizona |
| United States | Herbert Harris, Md, Phd, Pa | Chapel Hill | North Carolina |
| United States | RH Johnson VA Medical Center | Charleston | South Carolina |
| United States | Roper St. Francis Healthcare | Charleston | South Carolina |
| United States | ANI Neurology PLLC dba Alzheimer's Memory Center | Charlotte | North Carolina |
| United States | Galen Research | Chesterfield | Missouri |
| United States | CTI Clinical Research Center | Cincinnati | Ohio |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | Ericksen Research and Development | Clinton | Utah |
| United States | Columbus Research & Wellness Institute, INC | Columbus | Georgia |
| United States | Medical Research & Health Education Foundation, Inc. | Columbus | Georgia |
| United States | The Ohio State University | Columbus | Ohio |
| United States | Neurology Clinic, P.C. | Cordova | Tennessee |
| United States | ATP Clinical Research, Inc. Site #763 | Costa Mesa | California |
| United States | Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri |
| United States | Connecticut Clinical Research | Cromwell | Connecticut |
| United States | Neurology Consultants of Dallas, PA | Dallas | Texas |
| United States | Texas Neurology, P.A. | Dallas | Texas |
| United States | University Texas Southwestern Medical Center | Dallas | Texas |
| United States | Associated Neurologists, PC | Danbury | Connecticut |
| United States | NeuroStudies. Net, LLC | Decatur | Georgia |
| United States | Quantum Laboratories, Inc. | Deerfield Beach | Florida |
| United States | Lytle and Weiss, PLLC dba Clinical Trials of the Rockies | Denver | Colorado |
| United States | InSite Clinical Research Site #576 | DeSoto | Texas |
| United States | Moonshine Research Center, Inc | Doral | Florida |
| United States | Science Connections, LLC Site #814 | Doral | Florida |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Michigan State University Department of Neurology | East Lansing | Michigan |
| United States | Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island |
| United States | The Samuel & Alexia Bratton Memory Clinic | Easton | Maryland |
| United States | Alexian Brothers Neurosciences Institute | Elk Grove Village | Illinois |
| United States | Core Clinical Research Site #772 | Everett | Washington |
| United States | Health Initiatives Research | Fayetteville | Arkansas |
| United States | Clinical Research Solutions | Franklin | Tennessee |
| United States | University of Florida | Gainesville | Florida |
| United States | Behavioral Research Specialists, LLC | Glendale | California |
| United States | Finlay Medical Research Corp | Greenacres City | Florida |
| United States | Mir Neurology | Hagerstown | Maryland |
| United States | Geriatric and Adult Psychiatry LLC | Hamden | Connecticut |
| United States | Berma Research Group | Hialeah | Florida |
| United States | Direct Helpers Research Center | Hialeah | Florida |
| United States | Direct Helpers Research Center #801 | Hialeah | Florida |
| United States | Galiz Research | Hialeah | Florida |
| United States | Indago Research & Health Center, Inc. | Hialeah | Florida |
| United States | Maxblue Institute | Hialeah | Florida |
| United States | New Life Medical Research Center, Inc. | Hialeah | Florida |
| United States | Reliable Clinical Research,LLC | Hialeah | Florida |
| United States | Research in Miami, Inc | Hialeah | Florida |
| United States | The Research Center, Inc | Hialeah | Florida |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Houston Methodist Neurological Institute | Houston | Texas |
| United States | Indiana University School of Medicine | Indianapolis | Indiana |
| United States | Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana |
| United States | Irvine Center for Clinical Research | Irvine | California |
| United States | University of California, Irvine | Irvine | California |
| United States | University Hills Clinical Research | Irving | Texas |
| United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
| United States | Alphab Global Research #793 | Jupiter | Florida |
| United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
| United States | SIH Research, LLC | Kissimmee | Florida |
| United States | Omega Clinical Trials, LLC | La Habra | California |
| United States | Alzheimer's Research and Treatment Center #1 | Lake Worth | Florida |
| United States | Alzheimer's Research and Treatment Center #2 | Lake Worth | Florida |
| United States | Alzheimer's Research and Treatment Center #3 | Lake Worth | Florida |
| United States | Meridien Research Site #558 | Lakeland | Florida |
| United States | Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital | Lakewood | Ohio |
| United States | Sheenath Clinical Service Site #770 | Lakewood | California |
| United States | Geriatric Solutions, LLC | Las Vegas | Nevada |
| United States | Innovative Clinical Research, Inc. Site #819 | Lauderhill | Florida |
| United States | MidAmerica Neuroscience Research Foundation | Lenexa | Kansas |
| United States | The Birches at Newton / Family Medical Associates | Levittown | Pennsylvania |
| United States | Torrance Clinical Research Institute, Inc. Site #826 | Lomita | California |
| United States | Alliance for Wellness, Inc dba Alliance for Research | Long Beach | California |
| United States | Collaborative Neuroscience Network, LLC. | Long Beach | California |
| United States | Neurology Associates of Arlington | Mansfield | Texas |
| United States | Flora Baker Center for Alzheimer's Disease and Related Disorders | Marmora | New Jersey |
| United States | Wellness Clinical Research Site #824 | McKinney | Texas |
| United States | PRX Research Site #825 | Mesquite | Texas |
| United States | Advance Medical Research Center #1 | Miami | Florida |
| United States | Advance Medical Research Center #2 | Miami | Florida |
| United States | Advanced Medical Center Group | Miami | Florida |
| United States | AMB Research Center, Inc. | Miami | Florida |
| United States | BioMed Research Institute | Miami | Florida |
| United States | CCM Clinical Research Group | Miami | Florida |
| United States | Central Miami Medical Institute | Miami | Florida |
| United States | Clinical Research Associates of South Florida #1 | Miami | Florida |
| United States | Clinical Research Associates of South Florida #2 | Miami | Florida |
| United States | Coral Research Clinic Corp | Miami | Florida |
| United States | Dade Research Center Llc | Miami | Florida |
| United States | Finlay Medical Research Corp Site #552 | Miami | Florida |
| United States | First Class Medical Services Site #807 | Miami | Florida |
| United States | Future Care Solution, LLC | Miami | Florida |
| United States | Global Medical Institutes, LLC | Miami | Florida |
| United States | Homestead Associates in Research Site# 797 | Miami | Florida |
| United States | Hope Research Network LLC Site #773 | Miami | Florida |
| United States | Innova Clinical Trials | Miami | Florida |
| United States | International Research Associates, LLC | Miami | Florida |
| United States | Kendall Research Institute | Miami | Florida |
| United States | Miami Dade Medical Research Institute, LLC | Miami | Florida |
| United States | Miami Jewish Health Systems, Inc. | Miami | Florida |
| United States | Nuovida Research Center Corp. | Miami | Florida |
| United States | Optimus U Corp | Miami | Florida |
| United States | P&S RESEARCH, LLC. Site #805 | Miami | Florida |
| United States | Pharmax Research of South Florida | Miami | Florida |
| United States | Premier Clinical Research Institute, Inc. #1 | Miami | Florida |
| United States | Premier Clinical Research Institute, Inc. #2 | Miami | Florida |
| United States | Project 4 Research #1 | Miami | Florida |
| United States | Project 4 Research #2 | Miami | Florida |
| United States | Reliant Medical Research LLC Site #811 | Miami | Florida |
| United States | Research Institute of West Kendall | Miami | Florida |
| United States | The Neurology Research Group, LLC | Miami | Florida |
| United States | United Health Research Corp. #1 | Miami | Florida |
| United States | United Health Research Corp. #2 | Miami | Florida |
| United States | University of Miami | Miami | Florida |
| United States | Vitae Researrch Center LLC | Miami | Florida |
| United States | New Med Research, Inc Site #812 | Miami Gardens | Florida |
| United States | Agility Clinical Research, Inc. | Miami Lakes | Florida |
| United States | NorthStar Medical Research Site #778 | Middleburg Heights | Ohio |
| United States | The NeuroCognitive Institute | Mount Arlington | New Jersey |
| United States | Collier Neurologic Specialists, LLC | Naples | Florida |
| United States | Naples Research, Inc | Naples | Florida |
| United States | Coastal Connecticut Research, LLC | New London | Connecticut |
| United States | Bayside Clinical Research Site #556 | New Port Richey | Florida |
| United States | Columbia University Medical Center | New York | New York |
| United States | Eastside Comprehensive Medical Center, LLC | New York | New York |
| United States | Manhattan Behavioral Medicine, PLLC | New York | New York |
| United States | Shankle Clinic | Newport Beach | California |
| United States | Boston Center for Memory | Newton | Massachusetts |
| United States | Sentara Neurosciences Institute | Norfolk | Virginia |
| United States | Lazlo J. Mate, MD, PA | North Palm Beach | Florida |
| United States | Research Center for Clinical Studies, Inc. | Norwalk | Connecticut |
| United States | Research Centers of America, LLC | Oakland Park | Florida |
| United States | Sensible Healthcare | Ocoee | Florida |
| United States | IPS Research Company | Oklahoma City | Oklahoma |
| United States | Oklahoma Clinical Research Center | Oklahoma City | Oklahoma |
| United States | NRC Research Institute | Orange | California |
| United States | Nathan S. Kline Institute for Psychiatric Research #1 | Orangeburg | New York |
| United States | Nathan S. Kline Institute for Psychiatric Research #571 | Orangeburg | New York |
| United States | Combined Research Orlando Site #799 | Orlando | Florida |
| United States | Compass Research, LLC | Orlando | Florida |
| United States | Neurology Associates of Ormond Beach | Ormond Beach | Florida |
| United States | Four Rivers Clinical Research Inc. | Paducah | Kentucky |
| United States | IMIC Inc. | Palmetto Bay | Florida |
| United States | Innovation Medical Research Center | Palmetto Bay | Florida |
| United States | Innovation Medical Research Center Site #802 | Palmetto Bay | Florida |
| United States | California Neurological Services | Panorama City | California |
| United States | Havana Research Institute | Pasadena | California |
| United States | Havana Research Institute Site 787 | Pasadena | California |
| United States | Bronson Neurobehavioral Health | Paw Paw | Michigan |
| United States | University of West Florida | Pensacola | Florida |
| United States | Drexel University | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Banner Alzheimer's Institute | Phoenix | Arizona |
| United States | NoesisPharma, LLC | Phoenix | Arizona |
| United States | Neurostudies Inc. Site#796 | Port Charlotte | Florida |
| United States | Coastal Neurology, PA | Port Royal | South Carolina |
| United States | Alzheimer's Disease Center | Quincy | Massachusetts |
| United States | Psychiatry and Alzheimer's Care of Rochester, PLLC | Rochester | New York |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | Clinical Research Professionals | Saint Louis | Missouri |
| United States | PsychCare Consultants Research | Saint Louis | Missouri |
| United States | Suncoast Neuroscience Associates, Inc. | Saint Petersburg | Florida |
| United States | Veteran Affairs Medical Center, Salem Virginia | Salem | Virginia |
| United States | Pharmaceuticals Research Associates, Inc. | Salt Lake City | Utah |
| United States | Texas Medical Research Associates, L.L.C. | San Antonio | Texas |
| United States | Pacific Research Network, Inc. #1 | San Diego | California |
| United States | Pacific Research Network, Inc. #2 | San Diego | California |
| United States | VA San Diego Healthcare System | San Diego | California |
| United States | HB Clinical Trials Inc. | Santa Ana | California |
| United States | Syrentis Clinical Research | Santa Ana | California |
| United States | Roskamp Institute | Sarasota | Florida |
| United States | Behavioral Health Care Associates | Schaumburg | Illinois |
| United States | Perseverance Research Center, LLC | Scottsdale | Arizona |
| United States | J. Gary Booker, MD, APMC | Shreveport | Louisiana |
| United States | BG Neurology | Spartanburg | South Carolina |
| United States | Frontier Institute | Spokane | Washington |
| United States | Richmond Behavioral Associates | Staten Island | New York |
| United States | Olympian Clinical Research | Tampa | Florida |
| United States | University of South Florida | Tampa | Florida |
| United States | VICIS Clinical Research Inc. | Tampa | Florida |
| United States | Viking Clinical Research | Temecula | California |
| United States | Compass Research North, LLC | The Villages | Florida |
| United States | Bio Behavioral Health | Toms River | New Jersey |
| United States | Oakland Medical Research Site #762 | Troy | Michigan |
| United States | Tulsa Clinical Research, LLC | Tulsa | Oklahoma |
| United States | New Foundation Medical Group Clinical Trials | Tustin | California |
| United States | IPC Research | Waukesha | Wisconsin |
| United States | Neurology Research Institute Palm Beach, LLC #1 | West Palm Beach | Florida |
| United States | Neurology Research Institute Palm Beach, LLC #2 | West Palm Beach | Florida |
| United States | Burke Rehabilitation Hospital | White Plains | New York |
| United States | Abington Neurological Associates, LTD | Willow Grove | Pennsylvania |
| United States | Florida Premier Research Institute | Winter Park | Florida |
| United States | Neuropsychiatric Associates | Woodstock | Vermont |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. |
United States, Bulgaria, Canada, Czechia, France, Hungary, Italy, Poland, South Africa, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of participants using concomitant medications | up to 64 weeks | ||
| Primary | Number of Participants with any Treatment-Emergent Adverse Event | up to 64 weeks | ||
| Primary | Number of Participants with any Treatment-Emergent Serious Adverse Event | up to 64 weeks | ||
| Primary | Number of Participants with any abnormal, clinically significant Clinical Laboratory Value | up to 52 weeks | ||
| Primary | Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value | up to 52 weeks | ||
| Primary | Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding | up to 52 weeks | ||
| Primary | Number of participants with any abnormal, clinically significant vital sign value | up to 52 weeks | ||
| Primary | Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score | Baseline; Week 64 | ||
| Primary | Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score | Baseline; Week 52 | ||
| Primary | Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score | Baseline; Week 52 | ||
| Secondary | Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score | Baseline; Week 64 | ||
| Secondary | Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI) | Baseline; Week 52 | ||
| Secondary | Change from Baseline to Week 64 in the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score | Baseline; Week 64 | ||
| Secondary | Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score | Baseline; Week 52 | ||
| Secondary | Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score | PGIC (rated by caregiver) | Baseline; Week 52 | |
| Secondary | Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score | Baseline; Week 52 | ||
| Secondary | Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score | Baseline; Week 52 | ||
| Secondary | Change from Baseline to Week 52 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants from Study 17-AVP-786-305 | Baseline; Week 52 |
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