Actively Recruiting

Phase 2
Phase 3
Age: 55Years - 90Years
All Genders
NCT07284472

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

Led by Exciva GmbH · Updated on 2026-04-17

300

Participants Needed

14

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 55Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 55 to 90 years who can move independently, with a walker, or in a wheelchair
  • Previously diagnosed with Alzheimer's Disease dementia
  • Clinically significant moderate to severe agitation at screening and for at least 2 weeks prior
  • Agitation diagnosis meeting International Psychogeriatric Association provisional criteria
  • Caregiver able and willing to comply with study procedures and in contact with participant at least four days a week for two hours each day
Not Eligible

You will not qualify if you...

  • Diagnosis of dementia-related disease other than Alzheimer's Disease dementia
  • Agitation symptoms not caused by Alzheimer's Disease dementia
  • History of uncontrolled seizures or epilepsy
  • Presence of major or unstable medical illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Esperanza Clinical

Murrieta, California, United States, 92562

Actively Recruiting

2

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, United States, 46260

Actively Recruiting

3

Precise Research Centers

Flowood, Mississippi, United States, 39232

Actively Recruiting

4

Integrative Clinical Trials

Brooklyn, New York, United States, 11229

Actively Recruiting

5

Manhattan Behavioral Medicine

New York, New York, United States, 10036

Actively Recruiting

6

Insight Clinical Trials

Independence, Ohio, United States, 44131

Actively Recruiting

7

Oregon Health & Science University

Portland, Oregon, United States, 97239

Not Yet Recruiting

8

The Memory Clinic

Bennington, Vermont, United States, 05201

Not Yet Recruiting

9

Sunnybrook Health Sciences Centre

North York, Ontario, Canada, M4N 3M5

Not Yet Recruiting

10

Baycrest Centre for Geriatric Care

North York, Ontario, Canada, M6A 2E1

Not Yet Recruiting

11

Kawartha Centre

Peterborough, Ontario, Canada, K9H 294

Not Yet Recruiting

12

Ontario Shores Centre for Mental Health Sciences

Whitby, Ontario, Canada, L1N 5S9

Not Yet Recruiting

13

Scottish Brain Sciences

Edinburgh, Midlothian, United Kingdom, EH12 5PJ

Actively Recruiting

14

Scottish Brain Sciences

Aberdeen, North East Scotland, United Kingdom, AB25 2XE

Actively Recruiting

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Research Team

E

Exciva Clinical Studies

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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