Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type

Completed · Phase 3 · Has a placebo group

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

In brief

Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

Key facts

Study ID

NCT02442778

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

522

Starts

2015-11-11

Expected to finish

2019-09-09

Last updated by the study team

2022-09-09

Who can join

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

You may qualify if…

• Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
• The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
• The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
• Either out participants or residents of an assisted-living facility or a skilled nursing home
• Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is >=4 (moderately ill) at screening and baseline
• Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
• Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

You may not qualify if…

• Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
• 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)
• Participant with myasthenia gravis

Where it is running

• Territory Neurology & Research Institute — Tucson, Arizona, United States
• Health Initiatives Research — Fayetteville, Arkansas, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Irvine Center for Clinical Research — Irvine, California, United States
• California Neurological Services — Panorama City, California, United States
• Havana Research Institute — Pasadena, California, United States
• Pacific Research Network, Inc — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Viking Clinical Research — Temecula, California, United States
• Denver Neurological Research, LLC — Denver, Colorado, United States
• JEM Research Institute — Atlantis, Florida, United States
• Clinical Research Of Brandon, LLC — Brandon, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Moonshine Research Center, Inc — Doral, Florida, United States
• Science Connections, LLC — Doral, Florida, United States
• Finlay Medical Research Corp — Greenacres City, Florida, United States
• Indago Research & Health Center, Inc. — 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
• Maxblue Institute — Hialeah, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Alzheimer's Research and Treatment Center — Lake Worth, Florida, United States
• Brain and Spine Center — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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