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Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia

NCT07284472 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-17

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.

Conditions

  • Agitation Associated With Alzheimer's Disease Dementia

Interventions

DRUG

EXV-802

Specified dose twice daily

DRUG

Placebo

Specified dose twice daily

DRUG

EXV-801

Specified dose twice daily

Sponsors & Collaborators

  • Exciva GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2029-01-31
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07284472 on ClinicalTrials.gov