EXV-802 + EXV-801 for Alzheimer's Disease

(SERENADA Trial)

This trial tests the safety and effectiveness of two experimental pills, EXV-802 and EXV-801, for treating agitation in people with Alzheimer's Disease (AD). Participants will receive either one of the experimental treatments or a placebo (a pill with no active ingredients) for six weeks. Ideal candidates have been diagnosed with Alzheimer's dementia, experience moderate to severe agitation, and have had symptoms for at least two weeks. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research shows that the treatment EXV-802, which combines the approved drug dextromethorphan with the experimental drug EXV-801, is under study for its safety. Although detailed safety information is not yet available, dextromethorphan's approval for other uses indicates some known safety.

Earlier studies found EXV-801 to be safe and well-tolerated. Exciva reported that previous trials demonstrated the combination of dextromethorphan and EXV-801 was generally safe for participants.

Researchers are excited about EXV-801 and EXV-802 for Alzheimer's disease because these treatments offer new approaches compared to existing options. Unlike current treatments, which mainly focus on managing symptoms by affecting neurotransmitters like acetylcholine and glutamate, EXV-801 and EXV-802 target different pathways that may directly influence the progression of Alzheimer's disease. EXV-801 introduces a novel active ingredient that is designed to reduce the buildup of harmful proteins in the brain, potentially slowing down the disease. Meanwhile, EXV-802 employs a different mechanism that may protect brain cells from further damage. These innovative approaches could not only help manage symptoms better but also offer hope in altering the course of the disease itself.

Research shows that EXV-802 and EXV-801 are under study for their potential to help with agitation in Alzheimer's Disease. In this trial, participants will receive either EXV-802 or EXV-801. Studies have found that EXV-801, also known as valiltramiprosate, might improve cognitive function and brain health. Specifically, it has been linked to reduced brain shrinkage and stable cognitive abilities over time. EXV-802 is part of a treatment approach targeting the brain and nervous system. While direct evidence for treating agitation is still being gathered, these treatments appear promising based on their mechanisms and early results.¹³⁶⁷⁸