Start:
July 8, 2020
End:
December 2024
Enrollment:
750
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.
Minimum Age: 50 Years
Maximum Age: 90 Years
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Alabama | |
---|---|
Clinical Research Site
Birmingham,
AL
35294
Recruiting
| |
Arkansas | |
Clinical Research Site #840-081
Fort Smith,
AR
72901
Recruiting
| |
Clinical Research Site
La Jolla,
CA
92093
Recruiting
| |
Clinical Research Site
Oceanside,
CA
92056
Recruiting
| |
Clinical Research Site #840-064
Pasadena,
CA
91105
Recruiting
| |
Florida | |
Clinical Research Site
Atlantis,
FL
33462
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 #840-079
Tampa,
FL
33614
Recruiting
| |
Maryland | |
Clinical Research Site #840-049
Glen Burnie,
MD
21061
Recruiting
| |
Mississippi | |
Clinical Research Site
Hattiesburg,
MS
39401
Recruiting
| |
Clinical Research Site
West Long Branch,
NJ
07764
Recruiting
| |
Ohio | |
Clinical Research Site
Canton,
OH
44718
Recruiting
| |
Tennessee | |
Clinical Research Site
Cordova,
TN
38018
Recruiting
|
Lead: Otsuka Pharmaceutical Development & Commercialization, Inc.
Source: ClinicalTrials.gov ID: NCT04408755
An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health