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A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer’s Type


Brief Summary:

This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and
17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be


Inclusion Criteria:

– Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302,
12-AVR-131, or 17-AVP-786-305.

– Participants from Study 12-AVR-131 with a diagnosis of probable AD according to the
2011 National Institute on Aging-Alzheimer’s Association (NIA-AA) working group

– Either out-patients or residents of an assisted-living facility or a skilled nursing

– Participants from Study 12-AVR-131 who have clinically significant, moderate/severe
agitation at least 2 weeks prior to baseline

– Participants from Study 12-AVR-131 with a diagnosis of agitation that must meet the
International Psychogeriatric Association (IPA) provisional definition of agitation

– Participants from Study 12-AVR-131 with a Clinical Global Impression of Severity of
Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and

– Participants from Study 12-AVR-131 with a Mini-Mental State Examination (MMSE) score
between 6 and 26 (inclusive) at screening and baseline

Exclusion Criteria:

– Participants with co-existent clinically significant or unstable systemic diseases
that could confound the interpretation of the safety results of the study (e.g.,
malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable
pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated
cardiomyopathy, or unstable valvular heart disease)

– Participants determined to have a high imminent risk of falls during the study based
on a clinical evaluation by the investigator

– Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding


  • Behavioral Research Specialists, LLC, Glendale, California, United States, 91206
  • Irvine Center for Clinical Research, Irvine, California, United States, 92614
  • University of California, Irvine, Irvine, California, United States, 92697
  • Omega Clinical Trials, LLC, La Habra, California, United States, 90631
  • Collaborative Neuroscience Network, LLC., Long Beach, California, United States, 90806
  • Shankle Clinic, Newport Beach, California, United States, 92663
  • NRC Research Institute, Orange, California, United States, 92868
  • California Neurological Services, Panorama City, California, United States, 91402
  • Havana Research Institute, Pasadena, California, United States, 91105
  • Pacific Research Network, Inc. #1, San Diego, California, United States, 92103
  • Pacific Research Network, Inc. #2, San Diego, California, United States, 92103
  • VA San Diego Healthcare System, San Diego, California, United States, 92103
  • HB Clinical Trials Inc., Santa Ana, California, United States, 92704
  • Syrentis Clinical Research, Santa Ana, California, United States, 92705
  • Viking Clinical Research, Temecula, California, United States, 92591
  • New Foundation Medical Group Clinical Trials, Tustin, California, United States, 92780
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