Protocol 20-AVP-786-307: A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudetromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimers type
The goal of this study is to evaluate the safety, effectiveness and tolerability of a drug compound (AVP- 786) for the treatment of agitation associated with Alzheimer’s Disease. Alzheimer’s Disease causes loss of brain cells and problems with memory, thinking and behavior. Agitated behaviors, such as irritability and restlessness, physical and verbal aggression, and pacing and wandering are major problems in this condition, can be difficult to manage, and can impact your quality of life. AVP-786 is targeted at treating your agitation behaviors. Caregivers are being asked to take part in this research study because the participants may require assistance to complete study procedures and/or attend study visits. Participation in this study will last for approximately 20 weeks and include site visits throughout the study.
The primary objective is to:
-Evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo for the
treatment of agitation in patients with dementia of the Alzheimer s type
The secondary objectives are to:
-Evaluate the effects of AVP-786 compared to placebo on global assessments of severity and
improvement of agitation
-Evaluate the effects of AVP-786 compared to placebo on neuropsychiatric symptoms
-Evaluate the effects of AVP-786 compared to placebo on measures of quality of life and
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Patients 50 to 90 years of age (inclusive) with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to screening that interferes with daily routine per the Investigator's judgment, and who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions.
A Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) score of 4 or more.
Mini Mental State Examination (MMSE) score of 8 to 24 (inclusive) at Screening and Baseline
must have a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the patient.
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the
contact information above or email firstname.lastname@example.org and someone will assist you.
Your information will be shared only with the research study team for recruitment purposes and designated CTSI personnel for project quality
assurance and will remain confidential. Your information will be stored indefinitely. Should you no longer want this information to be provided
in the aforementioned ways, please contact email@example.com.