AVP-786 for Alzheimer's-related Agitation

Recruiting at165 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Avanir Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a combination of two drugs taken by mouth to help calm severe agitation in people with Alzheimer's disease by balancing brain chemicals.

Research Team

Eligibility Criteria

This trial is for people with Alzheimer's who show moderate-to-severe agitation. They must have been diagnosed according to specific criteria, need medication as judged by a doctor, and have had non-drug treatments tried first. A reliable caregiver must be involved. Those with non-Alzheimer's dementia or conditions like myasthenia gravis can't join.

Inclusion Criteria

You have been diagnosed with Alzheimer's Disease

I have a caregiver who can help me with my treatment and follows the study rules.

I have been diagnosed with Alzheimer's disease based on specific criteria.

Exclusion Criteria

My agitation is not due to Alzheimer's, pain, psychiatric disorders, or delirium.

My dementia is not mainly caused by Alzheimer's disease.

You have myasthenia gravis.

Treatment Details

Interventions

• AVP-786 (Other)
• Placebo (Other)

Trial Overview The study tests AVP-786 against a placebo to see if it helps calm agitation in Alzheimer's patients better than no treatment at all. Participants will not know whether they're getting the real medicine or the placebo.

Participant Groups

Group I: AVP-786 Experimental Treatment 1 Intervention

Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.

Group II: Placebo Placebo Group 1 Intervention

Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.

Who Is Running the Clinical Trial?

Avanir Pharmaceuticals

Lead Sponsor

Trials

32

Recruited

12,100+

Otsuka Pharmaceutical Development & Commercialization, Inc.

Lead Sponsor

Trials

271

Recruited

170,000+

John Kraus

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Medical Officer since 2023

MD, PhD

Tarek Rabah

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University