AVP-786 for Agitation in Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+302 other 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 AVP-786, an oral medication taken regularly, in people with Alzheimer's disease who have significant agitation. The goal is to see if it can reduce their agitation and improve their behavior.

Research Team

Eligibility Criteria

This trial is for adults with Alzheimer's Disease who have moderate to severe agitation that disrupts daily life. They must meet specific criteria for Alzheimer's diagnosis and agitation, have had these symptoms consistently for at least 2 weeks, and require medication. A caregiver must be present to assist and monitor changes, spending at least 2 hours a day with the participant.

Inclusion Criteria

You have been very agitated and disruptive in your daily routine for at least 2 weeks, and your doctor has prescribed medication for it.

You have been diagnosed with probable Alzheimer's Disease based on specific criteria from the National Institute on Aging-Alzheimer's Association.

You have been very agitated and disruptive to your daily routine for at least 2 weeks and have been prescribed medication for it.

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Exclusion Criteria

You have serious health conditions like cancer, uncontrolled diabetes, uncontrolled high blood pressure, or unstable heart, lung, kidney, or liver disease that could affect the study results.

You have dementia that is not caused by Alzheimer's disease, like dementia from strokes, Parkinson's disease, or substance abuse.

You have signs of being very restless, which are not caused by Alzheimer's disease or other mental or physical conditions.

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Treatment Details

Interventions

AVP-786 (Other)
Placebo (Other)

Trial OverviewThe study tests AVP-786 against a placebo to see if it can safely and effectively treat agitation in Alzheimer’s patients. Participants will randomly receive either the actual drug or a placebo without knowing which one they are taking.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: AVP-786; Dose 2Experimental Treatment1 Intervention

Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.

Group II: AVP-786; Dose 1Experimental Treatment1 Intervention

Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.

Group III: PlaceboPlacebo Group1 Intervention

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