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Deudextromethorphan Hydrobromide

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.

Table of Contents

What is AVP-786?

AVP-786 is an investigational medication being developed to treat agitation in patients with Alzheimer’s disease dementia[1][2]. 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[1][2].
  • Quinidine sulfate: This substance helps increase the effectiveness of deudextromethorphan in the body[1][2].

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[1][2]. 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[1][2].

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[1][2]. 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[1][2].

Ongoing Clinical Trials

AVP-786 is currently being evaluated in Phase 3 clinical trials[1][2]. These are large-scale studies designed to assess the efficacy, safety, and tolerability of the medication. The main goals of these trials are to:

  1. Evaluate how well AVP-786 works compared to a placebo in reducing agitation symptoms[1][2].
  2. Assess the safety of the medication and identify any potential side effects[1][2].
  3. Determine how well patients tolerate the medication[1][2].

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[1][2].

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[1][2]
  • Diagnosed with probable Alzheimer’s disease[1][2]
  • Experiencing moderate to severe agitation for at least 2 weeks[1][2]
  • Have a caregiver who can assist with the study requirements[1][2]

There are also several exclusion criteria, such as having certain other medical conditions or taking certain medications that might interfere with the study[1][2].

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[1][2]
  • Improved quality of life for patients and caregivers[1][2]
  • A new treatment option for a challenging aspect of Alzheimer’s disease[1][2]

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[1][2].

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.

Aspect Details
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

FAQ

  • What is the purpose of these clinical trials? The primary purpose of these clinical trials is to evaluate the efficacy, safety, and tolerability of AVP-786 (Deudextromethorphan Hydrobromide and Quinidine Sulfate) compared to placebo for treating agitation in patients with Alzheimer's dementia.
  • Who can participate in these trials? Participants must be between 50 and 90 years old, diagnosed with probable Alzheimer's disease, have moderate-to-severe agitation for at least 2 weeks, and meet specific criteria regarding cognitive function and agitation symptoms. Caregivers must also be willing to comply with study procedures.
  • What is the main outcome being measured in these trials? The primary efficacy endpoint is the change from baseline to the end of the efficacy period in the Cohen-Mansfield Agitation Inventory (CMAI) total score, which measures agitation levels in patients with dementia.
  • How long do the trials last? The maximum treatment period for these trials is 85 days, or approximately 12 weeks.
  • Are there any major exclusion criteria for these trials? Major exclusion criteria include having dementia predominantly of non-Alzheimer's type, a history of substance abuse within 12 months, serious risk of suicide, certain psychiatric disorders, and specific cardiac conditions such as QTc prolongation or history of complete heart block.

Ongoing Clinical Trials on Deudextromethorphan Hydrobromide

  • Study on the Effectiveness and Safety of AVP-786 (Quinidine Sulfate and Deudextromethorphan Hydrobromide) for Treating Agitation in Alzheimer’s Dementia Patients

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Denmark Estonia Germany Greece Poland +1

  • Study on AVP-786 for Treating Agitation in Alzheimer’s Dementia Patients

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Belgium Croatia Hungary Ireland The Netherlands Slovakia +2

Glossary

  • Agitation: A state of excessive physical movement and verbal activity, often associated with Alzheimer's disease, that can cause distress for patients and caregivers.
  • Alzheimer's disease: A progressive brain disorder that slowly destroys memory and thinking skills, and eventually the ability to carry out simple tasks.
  • AVP-786: The investigational drug combination of Deudextromethorphan Hydrobromide and Quinidine Sulfate being studied for treating agitation in Alzheimer's dementia.
  • CMAI (Cohen-Mansfield Agitation Inventory): A tool used to measure agitation levels in patients with dementia, serving as the primary efficacy endpoint in these trials.
  • Deudextromethorphan Hydrobromide: One of the active ingredients in AVP-786, a modified form of dextromethorphan that may help reduce agitation symptoms.
  • Efficacy: The ability of a drug to produce the desired effect or outcome in treating a condition.
  • MMSE (Mini-Mental State Examination): A widely used test of cognitive function, used in these trials to assess eligibility (scores between 8 and 24).
  • NPI-AA (Neuropsychiatric Inventory-Agitation/Aggression): A scale used to measure the frequency and severity of agitation and aggression in patients with dementia.
  • Phase 3 clinical trial: A large-scale study to confirm the safety and efficacy of a new treatment, typically conducted before seeking regulatory approval.
  • Placebo: An inactive substance used as a control in clinical trials to compare the effects of the investigational drug.
  • Quinidine Sulfate: A component of AVP-786 that helps increase the bioavailability of Deudextromethorphan Hydrobromide in the body.
  • QTc prolongation: An abnormal heart rhythm that can be potentially dangerous and is being monitored as a safety concern in these trials.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-avp-786-quinidine-sulfate-and-deudextromethorphan-hydrobromide-for-treating-agitation-in-alzheimers-dementia-patients/
  2. http://clinicaltrials.eu/trial/study-on-avp-786-for-treating-agitation-in-alzheimers-dementia-patients/