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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат EXV-802
  Specified dose twice daily
• Препарат Placebo
  Specified dose twice daily
• Препарат EXV-801
  Specified dose twice daily

Первичные конечные точки

• Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score [Срок оценки: Baseline to Week 6]

Вторичные конечные точки (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 [Срок оценки: Baseline to Week 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Польша · 10 центров

• Centrum Medyczne HCP Sp. z o.o. — Poznan
• Krakowska Akademia Neurologii — Krakow
• NZOZ Wroclawskie Centrum Alzheimerowskie — Wroclaw
• FutureMeds Wroclaw — Wroclaw
• NZOZ Neuromed M. i M. Nastaj Spolka Partnerska — Lublin
• RCMed Oddzial Sochaczew — Sochaczew
• ETG Neuroscience Sp. z o.o. — Warsaw
• Silmedic Sp. z o.o. — Katowice
• … и ещё 2 центра

США · 9 центров

• Esperanza Clinical — Murrieta
• Josephson Wallack Munshower Neurology PC — Indianapolis
• Precise Research Centers — Flowood
• Galen Research LLC — Chesterfield
• Integrative Clinical Trials — Brooklyn
• Manhattan Behavioral Medicine — New York
• Insight Clinical Trials — Independence
• Oregon Health & Science University — Portland
• … и ещё 1 центр

Италия · 6 центров

• Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Rome
• Universita degli Studi di Roma ''La Sapienza" - Azienda Ospedaliera Sant'Andrea — Rome
• Azienda Ospedaliera Cardinale Giovanni Panico — Tricase
• IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli — Brescia
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Main Campus — Milan
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone — Palermo

Словакия · 5 центров

• MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o. — Banská Bystrica
• Univerzitna nemocnica Bratislava — Bratislava
• EPAMED s r.o. — Košice
• Crystal Comfort S.R.O. — Vranov nad Topľou
• Medicinske Centrum Konzilium, s.r.o. — Dubnica nad Váhom

Испания · 5 центров

• Hospital Victoria Eugenia Cruz Roja Sevilla — Seville
• Hospital Universitario Rio Hortega — Valladolid
• Hospital Virgen de la Concha — Zamora
• Hospital Universitari Germans Trias i Pujol — Barcelona
• Hospital Clinico San Carlos — Madrid

Канада · 4 центра

• Sunnybrook Health Sciences Centre — North York
• Baycrest Centre for Geriatric Care — North York
• Kawartha Centre — Peterborough
• Ontario Shores Centre for Mental Health Sciences — Whitby

Чехия · 4 центра

• Brain-Soultherapy s.r.o. — Kladno
• NeuropsychiatrieHK, sro — Hradec Králové
• Psychiatrie-Ambulance s.r.o — Pilsen
• FNUSA - St. Anne's University Hospital Brno — Brno

Германия · 4 центра

• Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres — Böblingen
• Curiositas ad sanum Studien und Beratungs GmbH — Ebersberg
• TUM Klinikum rechts der Isar — München
• Praxis Dr. med. Kirsten Hahn — Berlin

Великобритания · 2 центра

• Scottish Brain Sciences — Edinburgh
• Scottish Brain Sciences — Aberdeen

Идентификаторы

NCT: NCT07284472 · EXV802-2-1 · 2024-517388-22-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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