A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).

Key facts

Study ID

NCT03594123

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

259

Starts

2018-10-11

Expected to finish

2022-09-19

Last updated by the study team

2023-11-14

Who can join

Age: 55 and older, up to 91. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have participated in the 331-14-213 study.
• Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.

You may not qualify if…

• Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.

Where it is running

• For additional information regarding sites, contact 844-687-8522 — Miami, Florida, United States

Full record on ClinicalTrials.gov

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