Clinical trial • Phase II/III • Neurology

dextromethorphan; deramciclane fumarate for Agitation in Alzheimer's disease dementia

Phase II/III trial of dextromethorphan; deramciclane fumarate for Agitation in Alzheimer's disease dementia.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Agitation in Alzheimer's disease dementia
Trial Stage
Phase II/III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
18-12-2025
First CTIS Authorization Date
28-04-2026

Trial design

Randomised, active investigational arms: exv-802 and exv-801; comparator: matching placebo. dose/schedule not specified in the provided data (exv-801 max daily dose reported as 60 mg in product data; exv-802 dose details not specified).-controlled Phase II/III trial across 38 sites in Czechia, Spain, Poland and others.

Randomised
Yes
Comparator
Active investigational arms: EXV-802 and EXV-801; Comparator: Matching Placebo. Dose/schedule not specified in the provided data (EXV-801 max daily dose reported as 60 mg in product data; EXV-802 dose details not specified).
Target Sample Size
102
Trial Duration For Participant
42

Eligibility

Recruits 102 Vulnerable population selected: participants with Alzheimer's disease dementia (isVulnerablePopulationSelected = true). Informed consent materials include Main ICF and Caregiver ICF documents and privacy notices; provisions for legally authorised representatives (LAR) are documented (e.g. 'Main ICF for participant_LAR' in country-specific materials). Caregiver information and caregiver-specific consent/ICF materials are provided. Materials are available in multiple country languages (EN, ES, PL, SK, IT, DE, CZ) as indicated by language-specific ICF and SIS documents..

Vulnerable Population
Vulnerable population selected: participants with Alzheimer's disease dementia (isVulnerablePopulationSelected = true). Informed consent materials include Main ICF and Caregiver ICF documents and privacy notices; provisions for legally authorised representatives (LAR) are documented (e.g. 'Main ICF for participant_LAR' in country-specific materials). Caregiver information and caregiver-specific consent/ICF materials are provided. Materials are available in multiple country languages (EN, ES, PL, SK, IT, DE, CZ) as indicated by language-specific ICF and SIS documents.

Inclusion criteria

  • {"criterion_text":"- 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 with a wheelchair.\n- A previously established diagnosis of AD dementia.\n- The participant meets definition for agitation which require treatment with medicines.\n- The severity of agitation is at least moderate."}

Exclusion criteria

  • {"criterion_text":"- The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.\n- The participant has symptoms of agitation that are due to psychiatric conditions other than AD dementia.\n- The participant has a history of uncontrolled seizures or a history of epilepsy.\n- The participant lacks a caregiver or support person who attends regularly to the participants’ needs."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory total score","definition_or_measurement_approach":"Change from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory (CMAI) total score; comparison of active vs placebo."}

Secondary endpoints

  • {"endpoint_text":"- EXV-802: Difference between active and placebo as measured by 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.","definition_or_measurement_approach":"Change from baseline to Week 6 in CGI-S score related to agitation; comparison EXV-802 vs placebo."}
  • {"endpoint_text":"- EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Caregiver Distress total score for agitation and aggression.","definition_or_measurement_approach":"Change from baseline to Week 6 in NPI-C Caregiver Distress total score for agitation/aggression; comparison EXV-802 vs placebo."}
  • {"endpoint_text":"- EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Irritability / Lability score.","definition_or_measurement_approach":"Change from baseline to Week 6 in NPI-C Irritability/Lability score; comparison EXV-802 vs placebo."}
  • {"endpoint_text":"- EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Sleep Disorders score.","definition_or_measurement_approach":"Change from baseline to Week 6 in NPI-C Sleep Disorders score; comparison EXV-802 vs placebo."}
  • {"endpoint_text":"- EXV-802: Difference between active and placebo in frequency and severity of adverse events and clinically relevant changes in relevant safety endpoints e.g.: •\tMini‐Mental State Examination (MMSE) •\tColumbia Suicide Severity Rating Scale (C-SSRS) score •\tClinical laboratory values •\tVital signs •\tElectrocardiograms (ECGs) •\tPhysical examination findings","definition_or_measurement_approach":"Frequency and severity of adverse events and changes in safety measures (MMSE, C-SSRS, labs, vital signs, ECGs, physical exam) compared between EXV-802 and placebo."}
  • {"endpoint_text":"- EXV-801: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in CMAI, CGI-S, NPI-C, exploratory PD markers (BDNF), and blood-based biomarkers (analysis limited to descriptive statistics, including the effect size).","definition_or_measurement_approach":"Change from baseline to Week 6 in CMAI, CGI-S, NPI-C; exploratory PD marker BDNF and blood-based biomarkers assessed descriptively (including effect size) for EXV-801 vs placebo."}
  • {"endpoint_text":"- EXV-801: Difference between active and placebo in frequency and severity of adverse events and clinically relevant changes in relevant safety endpoints e.g.: •\tMini‐Mental State Examination (MMSE) •\tColumbia Suicide Severity Rating Scale (C-SSRS) score •\tClinical laboratory values •\tVital signs •\tElectrocardiograms (ECGs) •\tPhysical examination findings","definition_or_measurement_approach":"Frequency and severity of adverse events and changes in safety measures (MMSE, C-SSRS, labs, vital signs, ECGs, physical exam) compared between EXV-801 and placebo."}

Recruitment

Registry Or Advocacy Recruitment
True, Amsterdam UMC Stichting (listed as Patient organisation/association) is included among third parties.
Digital Remote Recruitment
True, PatientGO app and associated digital materials (PatientGO App, PatientGO Data Consent Form, PatientGO EULA, PatientGO Privacy Policy, PatientGO Patient Info Sheet) are present and used for recruitment and participant communications.
Planned Sample Size
222
Recruitment Window Months
32
Consent Approach
Informed consent obtained using Main ICF documents; separate Caregiver ICF and SIS (subject information sheet) materials are provided. Provision for consent by a legally authorised representative (LAR) is indicated (e.g. 'Main ICF for participant_LAR' country-specific documents). Privacy notices and data consent forms are provided. Consent materials are available in multiple languages specific to participating countries (English, Spanish, Polish, Slovak, Italian, German, Czech as indicated by language-tagged documents).

Methods

  • Posters and flyers placed in clinics and public spaces (country-specific poster/flyer recruitment materials listed per member state).
  • Patient/caregiver brochures and flowcharts distributed to potential participants and caregivers (country-specific patient/caregiver brochures and flowcharts listed).
  • GP/clinician referral letters (GP letter available in recruitment materials).
  • PatientGO digital app-based recruitment and study information (PatientGO App, PatientGO Patient Info Sheet, PatientGO Privacy Policy, PatientGO Data Consent Form present in multiple countries).
  • Visit reminder cards and study visit guides for caregivers to support retention and scheduling.

Geography

Total Number Of Sites
38
Total Number Of Participants
222

Czechia

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
36
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
Gerontologické centrum
Contact Person Name
Iva Holmerová
Site Name
NeuropsychiatrieHK s.r.o.
Contact Person Name
Martin Vališ
Contact Person Email
valismar@seznam.cz
Site Name
Psychiatrie-ambulance s.r.o.
Contact Person Name
Veronika Sýkorová
Contact Person Email
veronikasykora@centrum.cz
Site Name
Brain-Soultherapy s.r.o.
Contact Person Name
Klaudia Vocičková Borzová
Contact Person Email
brain-soultherapy@seznam.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
Neurologie/Neurology
Contact Person Name
Lenka Krajčovičová
Contact Person Email
lenka.krajcovicova@fnusa.cz

Spain

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
42
Number Of Sites
5
Number Of Participants
30

Sites

Site Name
Hospital Universitario Rio Hortega
Department Name
Psychiatry
Contact Person Name
Juan Luis Muñoz Sanchez
Contact Person Email
jlmusa@icloud.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Neurologia
Contact Person Name
Pau Pastor Muñoz
Site Name
Hospital Clinico San Carlos
Department Name
Neurology/Institute of Neuroscience
Contact Person Name
Jordi Matias-Guiu
Contact Person Email
jordimatiasguiu@hotmail.com
Site Name
Complejo Asistencial De Zamora Hospital Provincial De Zamora
Department Name
Psychiatry
Contact Person Name
Manuel Angel Franco Martin
Contact Person Email
mfrancom@saludcastillayleon.es
Site Name
Hospital San Juan de Dios De Sevilla
Department Name
Instituto Neurológico Andaluz (INA)
Contact Person Name
Felix Viñuela Fernandez

Poland

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
38
Number Of Sites
10
Number Of Participants
60

Sites

Site Name
Clinhouse Sp. z o.o.
Contact Person Name
Klaudiusz Kumor
Contact Person Email
klaudiusz.kumor@cmclinhouse.pl
Site Name
Centrum Medyczne Hcp Sp. z o.o.
Contact Person Name
Przemysław Osip
Contact Person Email
Przemyslaw.osip@cmhcp.pl
Site Name
Futuremeds Sp. z o.o.
Contact Person Name
Aleksandra Herrera-Sokołowska
Site Name
Velocity Nova Sp. z o.o.
Contact Person Name
Monika Wrona
Contact Person Email
mwrona@velocityclinical.com
Site Name
Rcmed Oddzial Sochaczew
Contact Person Name
Małgorzata Fengler-Czeczko
Site Name
Krakowska Akademia Neurologii Sp. z o.o.
Contact Person Name
Monika Rudzińska-Bar
Contact Person Email
mrudzinska-bar@uafm.edu.pl
Site Name
NZOZ Wroclawskie Centrum Alzheimerowskie
Contact Person Name
Katarzyna Okopien
Contact Person Email
katarzyna.okopien@gmail.com
Site Name
Silmedic Sp. z o.o.
Contact Person Name
Ilona Palka-Kisielowska
Contact Person Email
ikisielowska@silmedic.pl
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
Contact Person Name
Marcin Nastaj
Contact Person Email
marcinnastaj@gmail.com
Site Name
Etg Neuroscience Sp. z o.o.
Contact Person Name
Aleksandra Karbowniczek

Slovakia

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
37
Number Of Sites
6
Number Of Participants
36

Sites

Site Name
Crystal Comfort s.r.o.
Department Name
Psychiatricka ambulancia
Contact Person Name
Dagmar Breznoscakova
Contact Person Email
dbreznoscakova@gmail.com
Site Name
Epamed s.r.o.
Department Name
Psychiatricka ambulancia
Contact Person Name
Eva Palova
Contact Person Email
palovae@hotmail.com
Site Name
University Hospital Bratislava
Department Name
Psychiatricka klinika
Contact Person Name
Maria Kralova
Contact Person Email
macula.kocuro@gmail.com
Site Name
MUDr. Beata Dupejova neurologicka ambulancia s.r.o.
Department Name
Neurologicka ambulancia
Contact Person Name
Beata Dupejova
Contact Person Email
dupejova@gmail.com
Site Name
Konzilium s.r.o.
Department Name
Neurologicka ambulancia
Contact Person Name
Magdalena Perichtova
Contact Person Email
perichtova.md@gmail.com
Site Name
Klinika AuraMedica
Department Name
Neurologicka ambulancia
Contact Person Name
Stanislav Sutovsky
Contact Person Email
nilusuto@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
38
Number Of Sites
6
Number Of Participants
36

Sites

Site Name
curiositas ad sanum Studien und Beratungs GmbH
Contact Person Name
Johannes Schwarz
Site Name
Praxis Dr. med. Kirsten Hahn
Contact Person Name
Kirsten Hahn
Contact Person Email
neurol.studien@gmail.com
Site Name
Pharmakologisches Studienzentrum Chemnitz GmbH
Contact Person Name
Ralf Bodenschatz
Site Name
Studienzentrum Dr. Bischof GmbH
Contact Person Name
Felix Bischof
Site Name
Zentrum für Psychiatrie Emmendingen
Contact Person Name
Michael Hüll
Contact Person Email
m.huell@zfp-emmendingen.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Neurologische Klinik, Ambulanz für neurokognitive Erkrankungen
Contact Person Name
Timo Grimmer
Contact Person Email
t.grimmer@tum.de

Italy

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
36
Number Of Sites
6
Number Of Participants
36

Sites

Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
UOC Neurologia
Contact Person Name
Franco Giubilei
Contact Person Email
franco.giubilei@uniroma1.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Department of Medical Care (DAI Medico)
Contact Person Name
Mario Barbagallo
Contact Person Email
mario.barbagallo@unipa.it
Site Name
Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli
Department Name
Dementia and Rehabilitation Unit
Contact Person Name
Barbara Borroni
Contact Person Email
bborroni@fatebenefratelli.eu
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
UOC Malattie Neurodegenerative
Contact Person Name
Daniele Urso
Contact Person Email
d.urso@piafondazionepanico.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SSD Neurologia - Malattie Neurodegenerative
Contact Person Name
Andrea Arighi
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Contact Person Name
Alessandro Martorana
Contact Person Email
martorana@med.uniroma2.it

Sponsor

Primary sponsor

Full Name
Exciva GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
sponsorDuties codes: 4
Name
Syneos Health Germany GmbH
Responsibilities
sponsorDuties codes: 1,10,11,12,15,2,5,6; includes EC applications, Patient concierge services and patient reimbursement, Safety reporting to CIRB for Unanticipated Problems

Third parties

  • {"country":"Switzerland","full_name":"Maxia Strategies GmbH","duties_or_roles":"sponsorDuties codes: 12, 5","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Netherlands","full_name":"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Syneos Health Germany GmbH","duties_or_roles":"sponsorDuties codes: 1,10,11,12,15,2,5,6; code 15 description: EC applications, Patient concierge services and patient reimbursement, Safety reporting to CIRB for Unanticipated Problems","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Amsterdam UMC Stichting","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Patient organisation/association"}

Investigational products

Investigational Product Name
EXV-802
Active Substance
dextromethorphan; deramciclane fumarate
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
1
Investigational Product Name
EXV-801
Active Substance
deramciclane
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
1
Maximum Dose
60 mg
Investigational Product Name
Matching Placebo
Modality
Other

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