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

Completed · Phase 3 · Has a placebo group

Conditions studied: Agitation in Patients 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) was to 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

NCT02442765

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

387

Starts

2015-07-23

Expected to finish

2019-02-27

Last updated by the study team

2023-02-13

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 patients 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

• Clinical Research Site — Scottsdale, Arizona, United States
• Clinical Research Site — Little Rock, Arkansas, United States
• Clinical Research Site#1 — Irvine, California, United States
• Clinical Research Site#2 — Irvine, California, United States
• Clinical Research Site — Long Beach, California, United States
• Clinical Research Site — Oceanside, California, United States
• Clinical Research Site — Orange, California, United States
• Clinical Research Site#1 — San Diego, California, United States
• Clinical Research Site#2 — San Diego, California, United States
• Clinical Research Site — Santa Ana, California, United States
• Clinical Research Site — Tustin, California, United States
• Clinical Research Site — Denver, Colorado, United States
• Clinical Research Site — Cromwell, Connecticut, United States
• Clinical Research Site — New London, Connecticut, United States
• Clinical Research Site — Norwalk, Connecticut, United States
• Clinical Research Site — Atlantis, Florida, United States
• Clinical Research Site — Boca Raton, Florida, United States
• Clinical Research Site — Brandon, Florida, United States
• Clinical Research Site#1 — Coral Gables, Florida, United States
• Clinical Research Site#2 — Coral Gables, Florida, United States
• Clinical Research Site#3 — Coral Gables, Florida, United States
• Clinical Research Site#1 — Deerfield Beach, Florida, United States
• Clinical Research Site — Doral, Florida, United States
• Clinical Research Site — Hialeah, Florida, United States
• Clinical Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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