AVP-786 for Agitation in Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+291 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a medication called AVP-786 on individuals who have taken part in previous studies. The goal is to see if this medication can help with their conditions over time.

Eligibility Criteria

This trial is for patients with Alzheimer's-related dementia who've completed certain earlier studies (15-AVP-786-301, 302, 12-AVR-131, or 17-AVP-786-305). They should be experiencing moderate to severe agitation and have a specific level of cognitive function. It's open to out-patients or those in assisted living/nursing homes but not for individuals at high risk of falls or with other serious health issues that could affect safety results.

Inclusion Criteria

I have been diagnosed with Alzheimer's Disease based on NIA-AA criteria.

I live at home, in an assisted living, or a skilled nursing facility.

Exclusion Criteria

I do not have any major health issues that could affect the study's safety results.

Participant Groups

The study tests the long-term safety and effectiveness of AVP-786 as a treatment for agitation in Alzheimer's disease patients. This extension includes participants from previous Phase 2 and Phase 3 trials on the same medication.

3Treatment groups

Experimental Treatment

Group I: AVP-786 (dose 3)Experimental Treatment1 Intervention

AVP-786 dose 3; capsules administered twice a day over a 52-week period

Group II: AVP-786 (dose 2)Experimental Treatment1 Intervention

AVP-786 dose 2; capsules administered twice a day over a 52-week period

Group III: AVP-786 (dose 1)Experimental Treatment1 Intervention

AVP-786 dose 1; capsules administered twice a day over a 52-week period