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AVP-786 for Agitation in Alzheimer's Disease
Study Summary
This trial will compare the effectiveness of AVP-786 to a placebo in treating Alzheimer's patients who are experiencing agitation.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 387 Patients • NCT02442765Trial Design
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- You have been very agitated and disruptive in your daily routine for at least 2 weeks, and your doctor has prescribed medication for it.You have been diagnosed with probable Alzheimer's Disease based on specific criteria from the National Institute on Aging-Alzheimer's Association.You have been very agitated and disruptive to your daily routine for at least 2 weeks and have been prescribed medication for it.The participant's agitation must match the definition agreed upon by a group of experts who study behavior changes in people with memory and thinking problems.You have a moderate level of agitation according to a specific scale.You have serious health conditions like cancer, uncontrolled diabetes, uncontrolled high blood pressure, or unstable heart, lung, kidney, or liver disease that could affect the study results.You have dementia that is not caused by Alzheimer's disease, like dementia from strokes, Parkinson's disease, or substance abuse.You have signs of being very restless, which are not caused by Alzheimer's disease or other mental or physical conditions.You have myasthenia gravis.You must be able to comply with study procedures.You are a caregiver who is willing and able to comply with all required study procedures
- Group 1: Placebo
- Group 2: AVP-786; Dose 1
- Group 3: AVP-786; Dose 2
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are currently enrolled in this experiment?
"This study requires 550 willing and eligible participants. Those who fit the bill can take part in this research from different locations, such as Insight Clinical Trials LLC in Beachwood, Ohio or Core Clinical Research Site # 772 in Everett, Washington."
What is the official standing of AVP-786 in relation to other medications?
"AVP-786 has received a score of 3 for safety. This is due to it being a Phase 3 trial, which implies that not only does some data support efficacy, but multiple rounds of data also support the safety of AVP-786."
Can patients currently enroll in this trial?
"That is correct, the online clinicaltrial registry indicates that this study is still enrolling patients. This particular trial began on October 13th, 2017 and was last updated September 23rd of this year. A total of 550 people are needed for the 31 different sites taking part in the research."
In how many different medical settings is this research being conducted?
"Currently, this research is being conducted at 31 sites around the United States of America. The locations in Beachwood, Everett and Lakeland as well as other cities. To limit travelling, patients are encouraged to enroll at a location nearest to them."
Does this research include octogenarians as participants?
"The minimum age limit for participants of this study is 50 and the maximum is 90."
How can I sign up for this clinical trial?
"This study is enrolling 550 patients with Alzheimer's disease aged 50 and 90. In order to qualify, patients must meet the following criteria: have a caregiver who is able and willing to comply with all required study procedures, be diagnosed with probable Alzheimer's Disease according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria, exhibit clinically significant moderate/severe agitation that interferes with their daily routine, and have a reliable caregiver who is able and willing to comply with study procedures."
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