A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI 1284 in Patients With Psychosis Associated With Alzheimer's Disease

Обзор

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.

Подробное описание

The study will be conducted in 3 periods:

* Screening Period (up to 4 weeks) during which patient eligibility will be assessed; * Double-blind Treatment Period (6 weeks) during which all patients will be randomized in a 1:1 ratio to receive either ITI-1284 or placebo; * Safety Follow-up Period (30 days) during which all patients will return for a safety follow-up visit approximately 30 days after the last dose of study drug.

Вмешательства

• Препарат ITI-1284
  ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
• Препарат Placebo
  Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Первичные конечные точки

• BEHAVE-AD psychosis subscale score [Срок оценки: Week 6]

Вторичные конечные точки (1)

• CGI-S score [Срок оценки: Week 6]

Критерии участия

Критерии включения

• Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \[LAR\]) before the initiation of any study-specific procedures in accordance with local regulations;
• Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:

• Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; or
• Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
• Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline;
• Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline;
• CGI-S score ≥ 4 at Screening and Baseline;
• Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures;
• Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver);

Критерии исключения

• Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (eg, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions:

• Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;
• Bipolar disorder;
• Risk for suicidal behavior during the course of their participation in the study or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and/or as assessed by C-SSRS; or the patient has had 1 or more suicide attempts within 2 years prior to Screening;
• The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee,
• The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
• The patient is bedridden or has any significant medical condition that is unstable and would either:

• Place the patient at undue risk from study drug or undergoing study procedures; or
• Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study;
• The patient is in hospice or end-of-life care;

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

США · 26 центров

• Advanced Research Center, Inc — Anaheim
• Pharmacology Research Institute — Los Alamitos
• Wr Pri Llc — Newport Beach
• ATP Clinical Research — Orange
• Sunwise Clinical Research — Walnut Creek
• Envision Trials LLC — Bonita Springs
• Clinical Research of Brandon — Brandon
• Healthcare Innovations Institute Inc — Coral Springs
• … и ещё 18 центров

Болгария · 8 центров

• Medical Center Sv Dimitar Blagoevgrad — Blagoevgrad
• Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Nats — Cherven Bryag
• Mental Health Centre Prof. N Shipkovenski EOOD — Sofia
• DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD — Sofia
• Medical Center Hera EOOD — Sofia
• Medical Center Intermedica, OOD — Sofia
• UMHAT Prof. Dr. St. Kirkovich AD — Stara Zagora
• Mental Health Center - Vratsa EOOD — Vratsa

Румыния · 6 центров

• Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila' — Bucharest
• Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1 — Bucharest
• Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia — Bucharest
• Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian — Bucharest
• Spitalul De Psihiatrie Elisabeta Doamna Galaţi — Galati
• SC Carpe Diem SRL — Sibiu

Словакия · 6 центров

• Neurologicka ambulancia MUDr.Dupejova s.r.o. — Banská Bystrica
• Univerzitna nemocnica Bratislava — Bratislava
• Univerzitna nemocnica L. Pasteura Kosice — Košice
• Epamed sro — Košice
• NEURES s r o — Krompachy
• Crystal Comfort s.r.o. — Vranov nad Topľou

Сербия · 5 центров

• Clinical Center Dr Dragisa Misovic Dedinje — Belgrade
• Special Hospital for Psychiatric Diseases Kovin — Kovin
• University Clinical Center Kragujevac — Kragujevac
• University Clinical Center NIS — Niš
• Special Hospital for Psychiatric Diseases Sveti Vracevi — Novi Kneževac

Хорватия · 4 центра

• Polyclinic Neuron — Zagreb
• University Hospital Centre Zagreb 1 — Zagreb
• University Hospital Centre Zagreb — Zagreb
• Psychiatric Clinic "VRAPCE" — Zagreb

Чехия · 4 центра

• Fakultni nemocnice u sv. Anny v Brne — Brno
• Neuro Health Centrum s r o — Brno
• NEUROHK s r o — Hradec Králové
• INEP medical s.r.o. — Prague

Польша · 3 центра

• Przychodnia Srodmiescie SP. z o.o. — Bydgoszcz
• Neuro Care — Katowice
• Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych UM im Piastow Slaskich we Wroclawi — Ścinawa

Испания · 3 центра

• Hosp. Gral. de Albacete — Albacete
• Hosp. Prov. de Zamora — Zamora
• Hosp. Viamed Montecanal — Zaragoza

Идентификаторы

NCT: NCT06540833 · ITI-1284-201 · ITI-1284-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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