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

NCT07284472 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: EXV802-2-12024-517388-22-00
• Study Type: interventional
• Target: 300
• Locations: 9 countries
• Sites: 49

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.

Conditions

Agitation Associated With Alzheimer's Disease Dementia

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

EXPERIMENTAL

Participants will be assigned to treatment with EXV-802 capsules administered twice a day over a 6-week period.

Drug: EXV-802

Placebo

PLACEBO COMPARATOR

Participants will be assigned to treatment with placebo capsules administered twice a day over a 6-week period.

Drug: Placebo

EXV-801

EXPERIMENTAL

Participants will be assigned to treatment with EXV-801 capsules administered twice a day over a 6-week period.

Drug: EXV-801

Interventions

EXV-802 DRUG

Specified dose twice daily

Also known as: Dextromethorphan + EXV-801

EXV-802

Placebo DRUG

Specified dose twice daily

Placebo

EXV-801 DRUG

Specified dose twice daily

Also known as: deramciclane

EXV-801

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Exciva GmbH: lead

Study Sites (49)

Esperanza Clinical

Murrieta, California, 92562, United States

RECRUITING

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, 46260, United States

RECRUITING

Precise Research Centers

Flowood, Mississippi, 39232, United States

RECRUITING

Galen Research LLC

Chesterfield, Missouri, 63005, United States

NOT YET RECRUITING

Integrative Clinical Trials

Brooklyn, New York, 11229, United States

RECRUITING

Manhattan Behavioral Medicine

New York, New York, 10036, United States

RECRUITING

Insight Clinical Trials

Independence, Ohio, 44131, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

NOT YET RECRUITING

The Memory Clinic

Bennington, Vermont, 05201, United States

RECRUITING

Sunnybrook Health Sciences Centre

North York, Ontario, M4N 3M5, Canada

NOT YET RECRUITING

Baycrest Centre for Geriatric Care

North York, Ontario, M6A 2E1, Canada

NOT YET RECRUITING

Kawartha Centre

Peterborough, Ontario, K9H 294, Canada

RECRUITING

Ontario Shores Centre for Mental Health Sciences

Whitby, Ontario, L1N 5S9, Canada

NOT YET RECRUITING

Brain-Soultherapy s.r.o.

Kladno, Central Bohemia, 272 01, Czechia

NOT YET RECRUITING

NeuropsychiatrieHK, sro

Hradec Králové, Hradec Králové Region, 500 02, Czechia

NOT YET RECRUITING

Psychiatrie-Ambulance s.r.o

Pilsen, Plzeň Region, 301 00, Czechia

NOT YET RECRUITING

FNUSA - St. Anne's University Hospital Brno

Brno, South Moravian, 602 00, Czechia

NOT YET RECRUITING

Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres

Böblingen, Baden-Wurttemberg, 71034, Germany

RECRUITING

Curiositas ad sanum Studien und Beratungs GmbH

Ebersberg, Bavaria, 85560, Germany

NOT YET RECRUITING

TUM Klinikum rechts der Isar

München, Bavaria, 81675, Germany

NOT YET RECRUITING

Praxis Dr. med. Kirsten Hahn

Berlin, State of Berlin, 13187, Germany

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

NOT YET RECRUITING

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

Rome, Lazio, 00189, Italy

NOT YET RECRUITING

Azienda Ospedaliera Cardinale Giovanni Panico

Tricase, Lecce, 73039, Italy

NOT YET RECRUITING

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, Lombardy, 25125, Italy

NOT YET RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Main Campus

Milan, Lombardy, 20122, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicily, 90127, Italy

NOT YET RECRUITING

Centrum Medyczne HCP Sp. z o.o.

Poznan, Greater Poland Voivodeship, 61-485, Poland

NOT YET RECRUITING

Krakowska Akademia Neurologii

Krakow, Lesser Poland Voivodeship, 31-505, Poland

NOT YET RECRUITING

NZOZ Wroclawskie Centrum Alzheimerowskie

Wroclaw, Lower Silesian Voivodeship, 53-659, Poland

NOT YET RECRUITING

FutureMeds Wroclaw

Wroclaw, Lower Silesian Voivodeship, 53-673, Poland

NOT YET RECRUITING

NZOZ Neuromed M. i M. Nastaj Spolka Partnerska

Lublin, Lublin Voivodeship, 20-064, Poland

NOT YET RECRUITING

RCMed Oddzial Sochaczew

Sochaczew, Masovian Voivodeship, 69-500, Poland

NOT YET RECRUITING

ETG Neuroscience Sp. z o.o.

Warsaw, Masovian Voivodeship, 02-677, Poland

NOT YET RECRUITING

Silmedic Sp. z o.o.

Katowice, Silesian Voivodeship, 40-282, Poland

RECRUITING

Clinhouse Sp. z o.o.

Zabrze, Silesian Voivodeship, 41-807, Poland

NOT YET RECRUITING

Velocity Clinical Research, Staszów

Staszów, Świętokrzyskie Voivodeship, 28-200, Poland

RECRUITING

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

Banská Bystrica, Banská Bystrica Region, 974 04, Slovakia

NOT YET RECRUITING

Univerzitna nemocnica Bratislava

Bratislava, Bratislava Kraj, 813 69, Slovakia

NOT YET RECRUITING

EPAMED s r.o.

Košice, Košice Region, 040 11, Slovakia

NOT YET RECRUITING

Crystal Comfort S.R.O.

Vranov nad Topľou, Presov, 093 01, Slovakia

NOT YET RECRUITING

Medicinske Centrum Konzilium, s.r.o.

Dubnica nad Váhom, Trenčín Region, 018 41, Slovakia

NOT YET RECRUITING

Hospital Victoria Eugenia Cruz Roja Sevilla

Seville, Andalusia, 41009, Spain

NOT YET RECRUITING

Hospital Universitario Rio Hortega

Valladolid, Castille and León, 47012, Spain

NOT YET RECRUITING

Hospital Virgen de la Concha

Zamora, Castille and León, 49029, Spain

NOT YET RECRUITING

Hospital Universitari Germans Trias i Pujol

Barcelona, Catalonia, 08916, Spain

NOT YET RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Scottish Brain Sciences

Edinburgh, Midlothian, EH12 5PJ, United Kingdom

RECRUITING

Scottish Brain Sciences

Aberdeen, North East Scotland, AB25 2XE, United Kingdom

RECRUITING

MeSH Terms

Interventions

Dextromethorphan; deramciclane

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Exciva Clinical Studies

CONTACT

+49 6221-6479990; studies@exciva.com

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: June 5, 2026

Record last verified: 2026-06

Locations

GB (2); US (9); CA (4); PL (10); ES (5); SL (5); DE (4); IT (6); CZ (4)