In short
Deramciclane fumarate is an investigational substance originally studied as an anxiolytic. It acts on serotonin receptors in the brain. The current clinical trial data shows it is being tested in a Phase 4 trial for agitation in people with Alzheimer's disease dementia. This trial plans to enroll 324 participants.
Key points
- Deramciclane fumarate is an investigational substance that acts on serotonin 5-HT2C receptors in the brain.
- It is being studied in a Phase 4 clinical trial for agitation in Alzheimer's disease dementia.
- The trial plans to enroll 324 participants.
- The main goal is to measure changes in the Cohen-Mansfield Agitation Inventory (CMAI) total score over 6 weeks.
- The study compares the active drug against a placebo.
- The trial is currently in the Authorised status, meaning it is approved but may not yet be recruiting.
What is deramciclane fumarate?
Deramciclane fumarate is an investigational substance that has been studied as a potential treatment for anxiety, known as an anxiolytic. It is also known by the development code EGIS-3886. The substance is not currently described as having a marketing authorisation in the provided data, suggesting it remains under investigation rather than being an approved medicine.
How does deramciclane fumarate work?
Deramciclane fumarate works by interacting with specific receptors in the brain. It binds with high affinity to serotonin 5-HT2A and 5-HT2C receptors. Research indicates it acts as an inverse agonist at the 5-HT2C receptor, which means it produces an effect opposite to that of the natural chemical messenger, serotonin, at this site. Studies have shown that deramciclane can occupy these receptors in the brain during treatment.
Which conditions is it used or studied for?
Based on the available data, deramciclane fumarate has been studied for the following condition:
- Agitation in Alzheimer's disease dementia: This is a common and distressing symptom in people with Alzheimer's, involving restlessness, aggression, or emotional distress. The current clinical trial aims to see if deramciclane can help reduce these symptoms.
Earlier research also explored its potential as an anxiolytic, a medicine for reducing anxiety.
How is deramciclane fumarate given?
The clinical trial data indicates that the substance is given orally, in a tablet form or as an oral solution. The specific dosage in the trial is recorded as EXV-801 (60 mg) and EXV-802 (0 mg), with the latter likely being a formulation code where the dose is not reported in the registry.
What do the clinical trials show?
The provided data contains one clinical trial for deramciclane fumarate, registered as NCT07284472. This is a Phase 4 interventional study, which is typically conducted after a medicine has been approved, to gather more information about its safety and effectiveness in a broader population or for a specific use.
What is the trial measuring?
The main goal of the trial is to measure how well the treatment reduces agitation symptoms. This is done using the Cohen-Mansfield Agitation Inventory (CMAI) total score, which is a standard tool used by caregivers to rate the frequency of agitated behaviours. The trial will look at the change in this score from the start of the study to week 6, comparing the active drug against a placebo.
Who can take part in the trial?
The trial is designed for people with agitation related to Alzheimer's disease dementia. It has a planned enrollment of 324 participants. The study status is 'Authorised', meaning it has received the necessary approvals to proceed.
What side effects are known?
The provided supplementary source does not list any specific side effects from clinical use. The available information focuses on its mechanism of action at serotonin receptors.