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Agitation Associated With Alzheimer's Disease DementiaPhase 2/3SERENADANCT07284472

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

A Phase 2/3 study testing EXV-802 and EXV-801 in people with Agitation Associated With Alzheimer's Disease Dementia, run by Exciva GmbH at 49 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 to 90 years
What is being tested?
EXV-802 and EXV-801
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
49 sitesin 9 countries
Study dates
2 Feb 2026to Feb 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

49 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Exciva Clinical Studies contact

+49 6221-6479990

studies@exciva.com

49 sites in 9 countries

Poland10 sites, 10 recruiting

  • Silmedic Sp. z o.o.

    Katowice, Silesian Voivodeship, 40-282

    Recruiting

  • Krakowska Akademia Neurologii

    Krakow, Lesser Poland Voivodeship, 31-505

    Recruiting

  • NZOZ Neuromed M. i M. Nastaj Spolka Partnerska

    Lublin, Lublin Voivodeship, 20-064

    Recruiting

  • Centrum Medyczne HCP Sp. z o.o.

    Poznan, Greater Poland Voivodeship, 61-485

    Recruiting

  • RCMed Oddzial Sochaczew

    Sochaczew, Masovian Voivodeship, 69-500

    Recruiting

  • Velocity Clinical Research, Staszów

    Staszów, Świętokrzyskie Voivodeship, 28-200

    Recruiting

  • ETG Neuroscience Sp. z o.o.

    Warsaw, Masovian Voivodeship, 02-677

    Recruiting

  • NZOZ Wroclawskie Centrum Alzheimerowskie

    Wroclaw, Lower Silesian Voivodeship, 53-659

    Recruiting

  • FutureMeds Wroclaw

    Wroclaw, Lower Silesian Voivodeship, 53-673

    Recruiting

  • Clinhouse Sp. z o.o.

    Zabrze, Silesian Voivodeship, 41-807

    Recruiting

Other trials in Poland

United States8 sites, 8 recruiting

  • The Memory Clinic

    Bennington, Vermont, 05201

    Recruiting

  • Integrative Clinical Trials

    Brooklyn, New York, 11229

    Recruiting

  • Precise Research Centers

    Flowood, Mississippi, 39232

    Recruiting

  • Insight Clinical Trials

    Independence, Ohio, 44131

    Recruiting

  • Josephson Wallack Munshower Neurology PC

    Indianapolis, Indiana, 46260

    Recruiting

  • Esperanza Clinical

    Murrieta, California, 92562

    Recruiting

  • Manhattan Behavioral Medicine

    New York, New York, 10036

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Recruiting

Other trials in United States

Italy7 sites, 7 recruiting

  • IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

    Brescia, Lombardy, 25125

    Recruiting

  • Azienda Sanitaria Locale (ASL) Chieti - Ospedale Policlinico "SS Annunziata''

    Chieti, 66100

    Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Main Campus

    Milan, Lombardy, 20122

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Sicily, 90127

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, Lazio, 00133

    Recruiting

  • Universita degli Studi di Roma ''La Sapienza" - Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189

    Recruiting

  • Azienda Ospedaliera Cardinale Giovanni Panico

    Tricase, Lecce, 73039

    Recruiting

Other trials in Italy

Slovakia5 sites, 5 recruiting

  • MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o.

    Banská Bystrica, Banská Bystrica Region, 974 04

    Recruiting

  • Univerzitna nemocnica Bratislava

    Bratislava, Bratislava Kraj, 813 69

    Not yet recruiting

  • Medicinske Centrum Konzilium, s.r.o.

    Dubnica nad Váhom, Trenčín Region, 018 41

    Recruiting

  • EPAMED s r.o.

    Košice, Košice Region, 040 11

    Recruiting

  • Crystal Comfort S.R.O.

    Vranov nad Topľou, Presov, 093 01

    Recruiting

Other trials in Slovakia

Spain5 sites, 5 recruiting

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, Catalonia, 08916

    Not yet recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Hospital Universitario Virgen de la Macarena

    Seville, Andalusia, 41009

    Recruiting

  • Hospital Universitario Rio Hortega

    Valladolid, Castille and León, 47012

    Recruiting

  • Hospital Virgen de la Concha

    Zamora, Castille and León, 49029

    Recruiting

Other trials in Spain

Canada4 sites, 4 recruiting

  • Sunnybrook Health Sciences Centre

    North York, Ontario, M4N 3M5

    Recruiting

  • Baycrest Centre for Geriatric Care

    North York, Ontario, M6A 2E1

    Recruiting

  • Kawartha Centre

    Peterborough, Ontario, K9H 294

    Recruiting

  • Ontario Shores Centre for Mental Health Sciences

    Whitby, Ontario, L1N 5S9

    Not yet recruiting

Other trials in Canada

Czechia4 sites, 4 recruiting

  • FNUSA - St. Anne's University Hospital Brno

    Brno, South Moravian, 602 00

    Recruiting

  • NeuropsychiatrieHK, sro

    Hradec Králové, Hradec Králové Region, 500 02

    Recruiting

  • Brain-Soultherapy s.r.o.

    Kladno, Central Bohemia, 272 01

    Recruiting

  • Psychiatrie-Ambulance s.r.o

    Pilsen, Plzeň Region, 301 00

    Recruiting

Other trials in Czechia

Germany4 sites, 4 recruiting

  • Praxis Dr. med. Kirsten Hahn

    Berlin, State of Berlin, 13187

    Recruiting

  • Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres

    Böblingen, Baden-Wurttemberg, 71034

    Recruiting

  • Curiositas ad sanum Studien und Beratungs GmbH

    Ebersberg, Bavaria, 85560

    Recruiting

  • TUM Klinikum rechts der Isar

    München, Bavaria, 81675

    Not yet recruiting

Other trials in Germany

United Kingdom2 sites, 2 recruiting

  • Scottish Brain Sciences

    Aberdeen, North East Scotland, AB25 2XE

    Recruiting

  • Scottish Brain Sciences

    Edinburgh, Midlothian, EH12 5PJ

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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).

Being tested
EXV-802, Placebo, EXV-801

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EXV-802Drug

    Also called Dextromethorphan + EXV-801

    Specified dose twice daily

  • PlaceboDrug

    Specified dose twice daily

  • EXV-801Drug

    Also called deramciclane

    Specified dose twice daily

Study groups in NCT07284472
Study groupRoleWhat they receive
EXV-802ExperimentalParticipants will be assigned to treatment with EXV-802 capsules administered twice a day over a 6-week period.
Receives: Drug: EXV-802
PlaceboPlacebo comparatorParticipants will be assigned to treatment with placebo capsules administered twice a day over a 6-week period.
Receives: Drug: Placebo
EXV-801ExperimentalParticipants will be assigned to treatment with EXV-801 capsules administered twice a day over a 6-week period.
Receives: Drug: EXV-801

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 6

Secondary outcomes (1)

  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

    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.

    Measured: Baseline to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start2 Feb 2026
  3. Primary completionJan 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07284472
Sponsor's protocol ID
EXV802-2-1
Other IDs
2024-517388-22-00
Acronym
SERENADA
Status last verified
Nov 2026
First submitted
27 Nov 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing EXV-802 and EXV-801 in people with Agitation Associated With Alzheimer's Disease Dementia, run by Exciva GmbH at 49 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Poland, United States, Italy, Slovakia, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Exciva Clinical Studies (+49 6221-6479990, studies@exciva.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07284472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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