Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Stopped early · Phase 3

Conditions studied: Agitation in Patients With Dementia of the Alzheimer's Type

In brief

This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.

Key facts

Study ID

NCT02446132

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

1197

Starts

2015-11-13

Expected to finish

2024-09-06

Last updated by the study team

2025-10-15

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NoesisPharma, LLC — Phoenix, Arizona, United States
• Perseverance Research Center, LLC — Scottsdale, Arizona, United States
• Health Initiatives Research — Fayetteville, Arkansas, United States
• Advanced Research Center, Inc. Site #835 — Anaheim, California, United States
• ATP Clinical Research, Inc. Site #763 — Costa Mesa, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Irvine Center for Clinical Research — Irvine, California, United States
• Sheenath Clinical Service Site #770 — Lakewood, California, United States
• Torrance Clinical Research Institute, Inc. Site #826 — Lomita, California, United States
• Collaborative Neuroscience Network, LLC. — Long Beach, California, United States
• Alliance for Wellness, Inc dba Alliance for Research Site #789 — Long Beach, California, United States
• NRC Research Institute — Orange, California, United States
• California Neurological Services — Panorama City, California, United States
• Havana Research Institute Site 787 — Pasadena, California, United States
• Havana Research Institute — Pasadena, California, United States
• Pacific Research Network, Inc. #1 — San Diego, California, United States
• Pacific Research Network, Inc. #2 — San Diego, California, United States
• HB Clinical Trials Inc. — Santa Ana, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Viking Clinical Research — Temecula, California, United States
• Lytle and Weiss, PLLC dba Clinical Trials of the Rockies — Denver, Colorado, United States
• Coastal Connecticut Research, LLC — New London, Connecticut, United States
• Research Center for Clinical Studies, Inc. — Norwalk, Connecticut, United States
• Neurology of Central Florida Rsch Ctr Site #803 — Altamonte Springs, Florida, United States
• MD First Research, LLC Site #767 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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