Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT07284472 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Agitation Associated With Alzheimer's Disease Dementia, sponsored by Exciva.

Recruiting
Registry status
Phase 2
Development phase
300
Enrollment target
13
Study locations

NCT07284472: Recruiting Phase 2 study of Agitation Associated With Alzheimer's Disease Dementia, sponsored by Exciva.

NCT07284472 is a Phase 2 study of Agitation Associated With Alzheimer's Disease Dementia that is actively recruiting participants, run by Exciva. The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT07284472, a Phase 2 study of Agitation Associated With Alzheimer's Disease Dementia, is actively recruiting participants, sponsored by Exciva.

RECRUITING
Registry status
Phase 2
Development phase
300 participants
Enrollment target
13
Study locations

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.

Primary Outcome

The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = o

Interventions

  • DRUG Placebo
  • DRUG EXV-802
  • DRUG EXV-801

Study Locations (13)

Ontario

  • Sunnybrook Health Sciences Centre - North York
  • Baycrest Centre for Geriatric Care - North York
  • Kawartha Centre - Peterborough
  • Ontario Shores Centre for Mental Health Sciences - Whitby

New York

  • Integrative Clinical Trials - Brooklyn
  • Manhattan Behavioral Medicine - New York

California

  • Esperanza Clinical - Murrieta

Indiana

  • Josephson Wallack Munshower Neurology PC - Indianapolis

Mississippi

  • Precise Research Centers - Flowood

Ohio

  • Insight Clinical Trials - Independence

Oregon

  • Oregon Health & Science University - Portland

Vermont

  • The Memory Clinic - Bennington

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2026-02-02
Est. Completion 2029-02
Phase Phase 2
Exciva

1 total trials

What NCT07284472 shows while recruiting

NCT07284472 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).

The record links to 1 condition, with Agitation Associated With Alzheimer's Disease Dementia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT07284472 lists 13 locations in 9 states (Ontario, New York, California).

Frequently Asked Questions

What is clinical trial NCT07284472 about?

NCT07284472 is a clinical study titled "Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia". 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.

What is the current status of trial NCT07284472?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2026-02-02. Estimated completion is 2029-02.

What conditions does trial NCT07284472 study?

This clinical trial studies the following conditions: Agitation Associated With Alzheimer's Disease Dementia.

What interventions are being tested in trial NCT07284472?

The interventions under investigation include: Placebo (DRUG), EXV-802 (DRUG), EXV-801 (DRUG).

Who is sponsoring clinical trial NCT07284472?

This trial is sponsored by Exciva, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07284472 being conducted?

This trial has 13 study locations across California, Indiana, Mississippi, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT07284472's enrollment target sits among peer trials

300 167th of 2000 higher than 1,813 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00353483 · 300 participants

    Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

  • NCT00588185 · 300 participants · NA

    [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer

  • NCT00682032 · 300 participants · NA

    The Effect of Beta-glucan in Non-Small Cell Lung Cancer

  • NCT00870064 · 300 participants · NA

    The Treatment of Type I Open Fractures in Pediatrics

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT07284472, the US trial registry maintained by the National Library of Medicine. NCT07284472 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.