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PlainTrials
RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing EXV-802 for Agitation Associated With Alzheimer's Disease Dementia

The goal of this clinical trial is to measure the safety and how well it works of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.

Official registry: https://clinicaltrials.gov/study/NCT07284472 · Exciva GmbH · enrollment listed as 300

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are EXV-802, Placebo, or EXV-801. The registry lists allocation as randomized. The goal of this clinical trial is to measure the safety and how well it works of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.

They plan to enroll about 300 people at 49 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase 2/3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants With Alzheimer's Disease Dementia

Interventions: EXV-802, Placebo, EXV-801

Primary outcome (registry wording): Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score

Who it is for (from inclusion criteria)

  • Ages 55 Years to 90 Years
  • The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker or a wheelchair
  • A previously established diagnosis of AD dementia
  • The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
  • The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation

Public study contact (from the registry)

Exciva Clinical Studies

+49 6221-6479990

studies@exciva.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

49 listed

+ 41 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07284472 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07284472?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07284472?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary