Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
SERENADA
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
2 other identifiers
interventional
300
3 countries
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2026
Typical duration for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2025
CompletedFirst Posted
Study publicly available on registry
December 16, 2025
CompletedStudy Start
First participant enrolled
February 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
April 17, 2026
March 1, 2026
2.9 years
November 27, 2025
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score
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 = once or twice a week, 4 = several times a week, 5 = once or twice a day, 6 = several times a day, 7 = several times an hour). The ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviors while lower scores indicate lower frequency of agitated behaviors The CMAI-IPA includes 19 items that were mapped to IPA agitation domains. The total score ranges from 19 to 133 with higher scores indicating more severity.
Baseline to Week 6
Secondary Outcomes (1)
Changes from baseline to endpoint (Week 6) in the Clinical Global Impression of Severity of Illness (CGI-S) score as related to symptoms of agitation
Baseline to Week 6
Other Outcomes (3)
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Caregiver Distress score for Agitation and Aggression domains
Baseline to Week 6
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Irritability/Liability Domain score
Baseline to Week 6
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Sleep Disorders Domain score
Baseline to Week 6
Study Arms (3)
EXV-802
EXPERIMENTALParticipants will be assigned to treatment with EXV-802 capsules administered twice a day over a 6-week period.
Placebo
PLACEBO COMPARATORParticipants will be assigned to treatment with placebo capsules administered twice a day over a 6-week period.
EXV-801
EXPERIMENTALParticipants will be assigned to treatment with EXV-801 capsules administered twice a day over a 6-week period.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.
- The participant has symptoms of agitation that are not secondary to AD dementia
- The participant has a history of uncontrolled seizures or a history of epilepsy.
- The participant has a major medical illness or unstable medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exciva GmbHlead
Study Sites (14)
Esperanza Clinical
Murrieta, California, 92562, United States
Josephson Wallack Munshower Neurology PC
Indianapolis, Indiana, 46260, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Integrative Clinical Trials
Brooklyn, New York, 11229, United States
Manhattan Behavioral Medicine
New York, New York, 10036, United States
Insight Clinical Trials
Independence, Ohio, 44131, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
Sunnybrook Health Sciences Centre
North York, Ontario, M4N 3M5, Canada
Baycrest Centre for Geriatric Care
North York, Ontario, M6A 2E1, Canada
Kawartha Centre
Peterborough, Ontario, K9H 294, Canada
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario, L1N 5S9, Canada
Scottish Brain Sciences
Edinburgh, Midlothian, EH12 5PJ, United Kingdom
Scottish Brain Sciences
Aberdeen, North East Scotland, AB25 2XE, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2025
First Posted
December 16, 2025
Study Start
February 2, 2026
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
April 17, 2026
Record last verified: 2026-03