RightFit
RecruitingPhase 2 / Phase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe EXV-802 and EXV-801 are and how well they treat agitation in people with Alzheimer's dementia. Agitation can mean being very restless or upset. The study is for adults ages 55 to 90 with moderate to severe agitation.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 55 to 90 years old and able to move around on your own, with a walker, or with a wheelchair.
  • Have an existing diagnosis of Alzheimer's dementia.
  • Have moderate to severe agitation at screening and for at least 2 weeks before being assigned to a study group.
  • Have agitation that meets the study's required medical definition.
  • Have a caregiver who is willing and able to follow all required study steps and has contact with you on at least 4 separate days, for at least 2 hours each day.

Who can't join

  • Have a confirmed main diagnosis of a dementia-related disease other than Alzheimer's dementia.
  • Have agitation that is not caused by Alzheimer's dementia.
  • Have a history of uncontrolled seizures or epilepsy, a condition that causes seizures.
  • Have a serious illness or a health condition that is not stable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: 1. 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. 2. A previously established diagnosis of AD dementia. 3. The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization 4. The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation. 5. Caregiver who is able and willing to comply with all required study procedures and who is in contact with the participant at least on four individual days for at least two hours per day. Exclusion criteria: 1. The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia. 2. The participant has symptoms of agitation that are not secondary to AD dementia 3. The participant has a history of uncontrolled seizures or a history of epilepsy. 4. The participant has a major medical illness or unstable medical condition

Study sites (9)

CA

IN

MO

MS

NY

OH

OR

VT