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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer’s Type


Brief Summary:

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786
compared to placebo, for the treatment of agitation in participants with dementia of the
Alzheimer’s type.


Inclusion Criteria:

– Diagnosis of probable Alzheimer’s Disease (AD) according to the 2011 National
Institute on Aging-Alzheimer’s Association (NIA-AA) working groups criteria

– Participants with clinically significant, moderate/severe agitation at the time of
screening and for at least 2 weeks prior to baseline that interferes with their daily
routine and for which a prescription medication has been indicated, in the opinion of
the investigator

– The diagnosis of agitation must meet the provisional consensus definition of agitation
in participants with cognitive disorders developed by the International
Psychogeriatric Association (IPA) Agitation Definition Work Group.

– A Clinical Global Impression of Severity of Illness scale for Agitation
(CGIS-Agitation) score of ≥ 4 (moderately ill) at screening and baseline

– Participants must have a reliable caregiver who is able and willing to comply with
study procedures, including not administering any prohibited medications during the
course of the study.

– Caregiver who is able and willing to comply with all required study procedures. In
order to qualify as a reliable informant (i.e., caregiver) capable of assessing
changes in participant’s condition during the study, the individual must spend a
minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

– Participants with dementia predominantly of the non-Alzheimer’s type (e.g., vascular
dementia, frontotemporal dementia, Parkinson’s disease, substance-induced dementia)

– Participants with symptoms of agitation that are not secondary to AD (e.g., secondary
to pain, other psychiatric disorder, or delirium)

– 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 with myasthenia gravis


  • Paradigm Clinical Research Centers, Inc., La Mesa, California, United States, 91942
  • Havana Research Institute, Pasadena, California, United States, 91105
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