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

June 4, 2026 updated by: Exciva GmbH

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 2/3 multicenter, double-blind, placebo-controlled, three-arm, multicenter study evaluating the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia. The diagnosis of agitation will be based on the consensus definition for agitation in patients with cognitive disorders developed by te International Psychogeriatric Association (IPA) Agitation Definition Work Group as well as neuroimaging performed after onset of dementia symptoms and a Core 1 AD biomarker.

The study will be conducted at up to 60 centers in the US, Canada and Europe.. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study. Approximately 100 patients per arm will be randomized (300 total).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • North York, Ontario, Canada, M4N 3M5
        • Not yet recruiting
        • Sunnybrook Health Sciences Centre
      • North York, Ontario, Canada, M6A 2E1
        • Not yet recruiting
        • Baycrest Centre for Geriatric Care
      • Peterborough, Ontario, Canada, K9H 294
        • Recruiting
        • Kawartha Centre
      • Whitby, Ontario, Canada, L1N 5S9
        • Not yet recruiting
        • Ontario Shores Centre for Mental Health Sciences
  • Czechia
    • Central Bohemia
      • Kladno, Central Bohemia, Czechia, 272 01
        • Not yet recruiting
        • Brain-Soultherapy s.r.o.
    • Hradec Králové Region
      • Hradec Králové, Hradec Králové Region, Czechia, 500 02
        • Not yet recruiting
        • NeuropsychiatrieHK, sro
    • Plzeň Region
      • Pilsen, Plzeň Region, Czechia, 301 00
        • Not yet recruiting
        • Psychiatrie-Ambulance s.r.o
    • South Moravian
      • Brno, South Moravian, Czechia, 602 00
        • Not yet recruiting
        • FNUSA - St. Anne's University Hospital Brno
  • Germany
    • Baden-Wurttemberg
      • Böblingen, Baden-Wurttemberg, Germany, 71034
        • Recruiting
        • Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres
    • Bavaria
      • Ebersberg, Bavaria, Germany, 85560
        • Not yet recruiting
        • Curiositas ad Sanum Studien und Beratungs GmBH
      • München, Bavaria, Germany, 81675
        • Not yet recruiting
        • TUM Klinikum rechts der Isar
    • State of Berlin
      • Berlin, State of Berlin, Germany, 13187
        • Not yet recruiting
        • Praxis Dr. med. Kirsten Hahn
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
      • Rome, Lazio, Italy, 00189
        • Not yet recruiting
        • Universita degli Studi di Roma ''La Sapienza" - Azienda Ospedaliera Sant'Andrea
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • Not yet recruiting
        • Azienda Ospedaliera Cardinale Giovanni Panico
    • Lombardy
      • Brescia, Lombardy, Italy, 25125
        • Not yet recruiting
        • IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
      • Milan, Lombardy, Italy, 20122
        • Not yet recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Main Campus
    • Sicily
      • Palermo, Sicily, Italy, 90127
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-485
        • Not yet recruiting
        • Centrum Medyczne HCP Sp. z o.o.
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-505
        • Not yet recruiting
        • Krakowska Akademia Neurologii
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-659
        • Not yet recruiting
        • NZOZ Wroclawskie Centrum Alzheimerowskie
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-673
        • Not yet recruiting
        • FutureMeds Wroclaw
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-064
        • Not yet recruiting
        • NZOZ Neuromed M. i M. Nastaj Spolka Partnerska
    • Masovian Voivodeship
      • Sochaczew, Masovian Voivodeship, Poland, 69-500
        • Not yet recruiting
        • RCMed Oddzial Sochaczew
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • Not yet recruiting
        • ETG Neuroscience Sp. z o.o.
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-282
        • Recruiting
        • Silmedic Sp. z o.o.
      • Zabrze, Silesian Voivodeship, Poland, 41-807
        • Not yet recruiting
        • Clinhouse Sp. z o.o.
    • Świętokrzyskie Voivodeship
      • Staszów, Świętokrzyskie Voivodeship, Poland, 28-200
        • Recruiting
        • Velocity Clinical Research, Staszów
  • Slovakia
    • Banská Bystrica Region
      • Banská Bystrica, Banská Bystrica Region, Slovakia, 974 04
        • Not yet recruiting
        • MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o.
    • Bratislava Kraj
      • Bratislava, Bratislava Kraj, Slovakia, 813 69
        • Not yet recruiting
        • Univerzitna nemocnica Bratislava
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 11
        • Not yet recruiting
        • EPAMED s r.o.
    • Presov
      • Vranov nad Topľou, Presov, Slovakia, 093 01
        • Not yet recruiting
        • Crystal Comfort s.r.o.
    • Trenčín Region
      • Dubnica nad Váhom, Trenčín Region, Slovakia, 018 41
        • Not yet recruiting
        • Medicinske Centrum Konzilium, s.r.o.
  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
    • Andalusia
      • Seville, Andalusia, Spain, 41009
        • Not yet recruiting
        • Hospital Victoria Eugenia Cruz Roja Sevilla
    • Castille and León
      • Valladolid, Castille and León, Spain, 47012
        • Not yet recruiting
        • Hospital Universitario Rio Hortega
      • Zamora, Castille and León, Spain, 49029
        • Not yet recruiting
        • Hospital Virgen de la Concha
    • Catalonia
      • Barcelona, Catalonia, Spain, 08916
        • Not yet recruiting
        • Hospital Universitari Germans Trias i Pujol
  • United Kingdom
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH12 5PJ
        • Recruiting
        • Scottish Brain Sciences
    • North East Scotland
      • Aberdeen, North East Scotland, United Kingdom, AB25 2XE
        • Recruiting
        • Scottish Brain Sciences
  • United States
    • California
      • Murrieta, California, United States, 92562
        • Recruiting
        • Esperanza Clinical
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Josephson Wallack Munshower Neurology PC
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Precise Research Centers
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Not yet recruiting
        • Galen Research LLC
    • New York
      • Brooklyn, New York, United States, 11229
        • Recruiting
        • Integrative Clinical Trials
      • New York, New York, United States, 10036
        • Recruiting
        • Manhattan Behavioral Medicine
    • Ohio
      • Independence, Ohio, United States, 44131
        • Recruiting
        • Insight Clinical Trials
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health & Science University
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Recruiting
        • The Memory Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EXV-802
Participants will be assigned to treatment with EXV-802 capsules administered twice a day over a 6-week period.
Drug: EXV-802
Specified dose twice daily
Other Names:
  • Dextromethorphan + EXV-801
Placebo Comparator: Placebo
Participants will be assigned to treatment with placebo capsules administered twice a day over a 6-week period.
Drug: Placebo
Specified dose twice daily
Experimental: EXV-801
Participants will be assigned to treatment with EXV-801 capsules administered twice a day over a 6-week period.
Drug: EXV-801
Specified dose twice daily
Other Names:
  • deramciclane

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score
Time Frame: Baseline to Week 6
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline to Week 6
The CGI-S is an observer-rated scale that measures illness severity. The CGI-S is a 7-point (1-7) scale (1 = normal, not at all ill; 7 = extremely ill) that assessed the severity of agitation in this study. Higher scores indicate severe agitation, while the lower scores indicate little or no agitation.
Baseline to Week 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Caregiver Distress score for Agitation and Aggression domains
Time Frame: Baseline to Week 6
The NPI-C is a retrospective interview covering 14 neuropsychiatric symptom domains. The NPI-C version of the NPI scale was designed to be administered by the clinician to the participant and the caregiver. The caregiver is first asked to provide frequency, severity, and distress ratings for each individual item across the domains. Frequency is rated on a scale from 0 to 4. Severity is rated on a scale from 0 to 3. Separately, the rater interviews the patient to assess frequency (0 to 4) of each item. Clinician rating of clinical impression is a severity rating (0 to 3) based on all available clinical and interview information. For this endpoint, the caregiver distress will be analyzed for the agitation and aggression domains. Caregiver distress is rated on a scale from 0 to 5 with a total score range of 0 to 10 across the 2 domains. Higher scores indicate greater caregiver distress.
Baseline to Week 6
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Irritability/Liability Domain score
Time Frame: Baseline to Week 6
The NPI-C is a retrospective interview covering 14 neuropsychiatric symptom domains. The NPI-C version of the NPI scale was designed to be administered by the clinician to the participant and the caregiver. The caregiver is first asked to provide frequency, severity, and distress ratings for each individual item across the domains. Frequency is rated on a scale from 0 to 4. Severity is rated on a scale from 0 to 3. Separately, the rater interviews the patient to assess frequency (0 to 4) of each item. Clinician rating of clinical impression is a severity rating (0 to 3) based on all available clinical and interview information. The score for the irritability/lability domain is the sum of clinical impression ratings of all items. There are 12 items in the irritability/lability domain. The minimum score for the irritability/lability domain is 0 and maximum score per domain is 36, with higher scores indicate greater symptom severity.
Baseline to Week 6
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Sleep Disorders Domain score
Time Frame: Baseline to Week 6
The NPI-C is a retrospective interview covering 14 neuropsychiatric symptom domains. The NPI-C version of the NPI scale was designed to be administered by the clinician to the participant and the caregiver. The caregiver is first asked to provide frequency, severity, and distress ratings for each individual item across the domains. Frequency is rated on a scale from 0 to 4. Severity is rated on a scale from 0 to 3. Separately, the rater interviews the patient to assess frequency (0 to 4) of each item. Clinician rating of clinical impression is a severity rating (0 to 3) based on all available clinical and interview information. The score for the sleep disorders domain is the sum of clinical impression ratings of all items. There are 8 items in the sleep disorders domain. The minimum score for the sleep disorders domain is 0 and maximum score per domain is 24, with higher scores indicate greater symptom severity.
Baseline to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Exciva GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EXV802-2-1
  • 2024-517388-22-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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