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20-AVP-786-306

Assessment of the efficacy, safety, and tolerability of AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer's type

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc
Phase
Drug
AVP-786

Information about the drug that will be tested in the study

Administration

A capsule taken orally twice a day

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected at random to either receive one of the following options:

  • A capsule of AVP-786 administered twice daily
  • One placebo capsule (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect) administered twice daily.

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of this study is to evaluate the efficacy, safety, and tolerability of AVP-786 for the treatment of agitation in people with dementia of the Alzheimer's type.

How long will the treatment last?

12 weeks

What your involvement will entail?

During the study, participants will be asked to complete tests that will assess their agitation (i.e. tests like CMAI and CGI-S).

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be between 50 and 90 years old
  • Have a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
  • Participant with clinically significant, moderate-to-severe agitation that interferes with daily routine
  • Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
  • Have a study partner who has a sufficient contact with the participant is willing to participate in study procedures throughout the study duration (i.e., study partner who spends a minimum of 2 hours per day for 4 days per week with the participant).
Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

  • Participant with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • Participant with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium)
  • Participant with unstable systemic diseases or conditions that in the opinion of the investigator would interfere with the conduct of the study (e.g., poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease)
  • Participant with myasthenia gravis (this is a long-term neuromuscular disease).

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Information for your doctor

EudraCT Number

2020-000798-26

Clinicaltrials.gov identifier

NCT04408755

Study contact information

  clinicaldevelopment@otsuka-us.com

Link to full text

https://clinicaltrials.gov/ct2/show/NCT04408755

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on May 2022.

 
Acknowledgement

Alzheimer Europe's Clinical Trials Watch database was developed as part of the 2018 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).

Alzheimer Europe gratefully acknowledges the support of its corporate sponsors for the update and maintenance of the database.

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