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AVP-786 for Moderate-to-Severe Agitation in People With Alzheimer's Disease

Start: July 8, 2020
End: December 31, 2024
Enrollment: 750

What Is This Study About?

This Phase 3 clinical trial will evaluate the effects and safety of AVP-786, to treat people with moderate-to-severe agitation due to Alzheimer's disease. AVP-786 is a combination of a drug approved by the FDA as a cough suppressant and a second drug which makes the first last longer in the body. Initially, all participants will undergo a screening evaluation to remove anyone whose agitation symptoms can be reduced without medication. The remaining participants will be randomly assigned to take either AVP-786 or a placebo, by tablet, twice a day for up to 12 weeks. Researchers will monitor participants for any side effects and measure changes in the severity of the agitation, including the types and frequency of behaviors.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 90 Years

Must have:

  • Diagnosis of probable Alzheimer's disease
  • Significant, moderate-to-severe agitation that interferes with daily routine for at least two weeks prior to study screening
  • Availability of a reliable caregiver who:
    • spends a minimum of two hours each day at least four days a week with the participant
    • is willing and able to comply with all study procedures, including daily administration of the study drug to the participant

Must NOT have:

  • Dementia that is due to another condition or disease, other than Alzheimer's disease (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • Agitation symptoms due to another condition or disease, other than Alzheimer's  (e.g., secondary to pain, other psychiatric disorder, delirium)
  • Agitation symptoms that can be managed without medication
  • Clinically significant or unstable condition or diseases that could interfere with the study, including:
    • Malignant cancer
    • Uncontrolled diabetes
    • Uncontrolled high blood pressure
    • Unstable heart, kidney, or liver disease
    • Diagnosis of myasthenia gravis

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 
Study Contact
Clinical Transparency

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Alabama
Clinical Research Site
Birmingham, AL 35294
Recruiting
Arkansas
Clinical Research Site
Little Rock, AR 72205
Recruiting
California
Clinical Research Site
Irvine, CA 92697
Recruiting
Clinical Research Site
La Jolla, CA 92093
Recruiting
Clinical Research Site
Oceanside, CA 92056
Recruiting
Florida
Clinical Research Site
Atlantis, FL 33462
Recruiting
Clinical Research Site
Brandon, FL 33511
Recruiting
Clinical Research Site
Coral Gables, FL 33134
Recruiting
Clinical Research Site
Doral, FL 33166
Recruiting
Clinical Research Site
Jacksonville, FL 32256
Recruiting
Clinical Research Site
Kissimmee, FL 34744
Recruiting
Clinical Research Site #840-069
Maitland, FL 32751
Recruiting
Clinical Research Site
Miami, FL 33126
Recruiting
Clinical Research Site
Miami, FL 33175
Recruiting
Clinical Research Site
Miami, FL 33467
Recruiting
Clinical Research Site
Orlando, FL 32819
Recruiting
Clinical Research Site
Palm Beach Gardens, FL 33410
Recruiting
Clinical Research Site
Pompano Beach, FL 33064
Recruiting
Clinical Research Site
Tampa, FL 33613
Recruiting
Clinical Research Site
Tampa, FL 33634
Recruiting
Hawaii
Clinical Research Site
Honolulu, HI 96817
Recruiting
Mississippi
Clinical Research Site
Hattiesburg, MS 39401
Recruiting
New Jersey
Clinical Research Site
Mount Arlington, NJ 07856
Recruiting
Clinical Research Site
West Long Branch, NJ 07764
Recruiting
New York
Clinical Research Site #840-072
New Windsor, NY 12553
Recruiting
North Carolina
Clinical Research Site
Winston-Salem, NC 27157
Recruiting
Ohio
Clinical Research Site
Canton, OH 44718
Recruiting
Clinical Research Site
Columbus, OH 43210
Recruiting
Clinical Research Site
Westerville, OH 43082
Recruiting
Oklahoma
Clinical Research Site
Edmond, OK 73012
Recruiting
Clinical Research Site
Oklahoma City, OK 73106
Recruiting
Pennsylvania
Clinical Research Site
Moosic, PA 18507
Recruiting
Tennessee
Clinical Research Site
Cordova, TN 38018
Recruiting
Texas
Clinical Research Site
The Woodlands, TX 77381
Recruiting
Virginia
Clinical Research Site #025
Richmond, VA 23236
Recruiting

Who Sponsors This Study?

Lead: Otsuka Pharmaceutical Development & Commercialization, Inc.

Source: ClinicalTrials.gov ID: NCT04408755