Treatment of Agitation in Alzheimer's Disease
Protocol: STUDY00005311
Full Title
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
Description
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.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
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.
Age Group: Adults
Principal Investigator: KINGA SZIGETI
ClinicalTrials.gov: Open Study
Contact(s)
CONNIE BRAND
conniebr@buffalo.edu
+1 716-323-0549
Want to Learn More?

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