In short
This article discusses clinical trials investigating the use of Deudextromethorphan Hydrobromide, combined with Quinidine Sulfate (AVP-786), for treating agitation in patients with Alzheimer's dementia. These Phase 3 studies aim to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo in managing agitation symptoms associated with Alzheimer's disease.
At a glance
- Study Type
- Phase 3, multicenter, randomized, double-blind, placebo-controlled
- Primary Objective
- Evaluate efficacy, safety, and tolerability of AVP-786 for agitation in Alzheimer's dementia
- Participant Age Range
- 50 to 90 years old
- Key Inclusion Criteria
- Probable Alzheimer's disease, moderate-to-severe agitation, MMSE score 8-24, NPI-AA score ≥4
- Primary Endpoint
- Change in CMAI total score from baseline to end of efficacy period
- Key Secondary Endpoint
- Change in CGI-S score related to agitation
- Treatment Duration
- Up to 85 days
- Investigational Drug
- AVP-786 (Deudextromethorphan Hydrobromide/Quinidine Sulfate)
- Key Exclusion Criteria
- Non-Alzheimer's dementia, recent substance abuse, serious suicide risk, certain psychiatric disorders, specific cardiac conditions
What is AVP-786?
AVP-786 is an investigational medication being developed to treat agitation in patients with Alzheimer's disease dementia. It is a combination of two active ingredients:
- Deudextromethorphan hydrobromide (also known as d6-DM): This is a modified version of dextromethorphan, a common cough suppressant.
- Quinidine sulfate: This substance helps increase the effectiveness of deudextromethorphan in the body.
How does AVP-786 work?
While the exact mechanism of action is not fully understood, AVP-786 is believed to work on certain receptors in the brain that may help reduce agitation and improve behavior in people with Alzheimer's disease. The deudextromethorphan component is thought to be the main active ingredient, while the quinidine helps keep more of it in the body for a longer time, potentially increasing its effectiveness.
What conditions does AVP-786 treat?
AVP-786 is specifically being studied for the treatment of agitation in patients with dementia of the Alzheimer's type. Agitation is a common and distressing symptom in Alzheimer's disease, which can include:
- Restlessness
- Pacing
- Verbal or physical aggression
- Irritability
- Resistance to care
These symptoms can be very challenging for both patients and caregivers, and currently, there are limited treatment options available.
Ongoing Clinical Trials
AVP-786 is currently being evaluated in Phase 3 clinical trials. These are large-scale studies designed to assess the efficacy, safety, and tolerability of the medication. The main goals of these trials are to:
- Evaluate how well AVP-786 works compared to a placebo in reducing agitation symptoms.
- Assess the safety of the medication and identify any potential side effects.
- Determine how well patients tolerate the medication.
The trials are using standardized scales to measure changes in agitation symptoms, including the Cohen-Mansfield Agitation Inventory (CMAI) and the Clinical Global Impression of Severity (CGI-S) scale.
Who can participate in the trials?
The clinical trials for AVP-786 have specific criteria for participation. Generally, eligible participants include:
- Men and women aged 50 to 90 years
- Diagnosed with probable Alzheimer's disease
- Experiencing moderate to severe agitation for at least 2 weeks
- Have a caregiver who can assist with the study requirements
There are also several exclusion criteria, such as having certain other medical conditions or taking certain medications that might interfere with the study.
Potential Benefits and Risks
As AVP-786 is still in clinical trials, its full benefits and risks are not yet known. However, potential benefits could include:
- Reduction in agitation symptoms
- Improved quality of life for patients and caregivers
- A new treatment option for a challenging aspect of Alzheimer's disease
Potential risks and side effects are being closely monitored in the trials. Patients with certain heart conditions or a history of substance abuse are excluded from the trials, suggesting these could be areas of concern.
It's important to note that as an investigational drug, AVP-786 is not yet approved for use outside of clinical trials. Patients and caregivers interested in this potential treatment should discuss current available options with their healthcare provider.