Skip to main content

8110 Gatehouse Road, Falls Church, VA 22042

Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (ASPECT)

Translate

General Information

Age Group

Adults

Status

Recruiting

Protocol Number

20-AVP-786-307

Background Information

The ASPECT study is designed to evaluate the efficacy, safety, and tolerability of AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer’s type.

ClinicalTrials.gov Identifier: NCT04464564

Offered At

Inova Medical Group – Neurology
8081 Innovation Park Dr., #900
Fairfax, VA 22031

Eligibility Information

  • Adults 50 to 90 years of age
  • Diagnosis of probable Alzheimer’s disease according to the 2011 NIA-AA working groups criteria. Either outpatients or residents of an assisted living facility, a skilled nursing home, a dementia unit, or any other type of facility providing long-term care
  • Clinically significant, moderate-to-severe agitation for at least 2 weeks prior to screening that interferes with daily routine
  • Caregiver must be willing and able to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the study. The caregiver must spend a minimum of 2 hours with the patient per day for at least 4 days per week to qualify as caregiver

Ineligibility Information

  • Caregiver is unwilling or unable, in the opinion of the Investigator, to comply with study instructions
  • Patient has dementia predominantly of non-Alzheimer’s type (eg, vascular dementia, frontotemporal dementia, Parkinson’s disease, substance-induced dementia)
  • Patients with symptoms of agitation that are not secondary to Alzheimer’s dementia (eg, secondary to pain, other psychiatric disorder, or delirium)
  • Patients with myasthenia gravis (contraindication for quinidine)
  • Patients with history of postural syncope or any history of unexplained syncope (evaluated on a case-by-case basis) within 12 months of Baseline
  • Patients with a history of substance and/or alcohol abuse within 12 months of Baseline
  • Patients determined to have a high imminent risk of falls during the study based on a clinical evaluation by the Investigator
  • Patients with known hypersensitivity to DM, Q, opiate drugs (codeine, etc), or any other ingredient of the study drug

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04464564?term=20-AVP-786-307&draw=2&rank=1