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

Official title

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

Overview

This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia

Detailed description

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 (12 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.

Interventions

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

Primary outcome measures

• Cohen-Mansfield Agitation Inventory (CMAI) total score [Time frame: Week 12]

Secondary outcome measures (1)

• Clinical Global Impression-Severity (CGI-S) Score [Time frame: Week 12]

Eligibility criteria

Inclusion criteria

• 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 Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:

• Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening; or
• Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
• Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition
• Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;
• CGI-S score ≥ 4 at Screening and Baseline;
• Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;

Exclusion criteria

• Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;
• 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;
• Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;
• Has a significant 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 Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening;
• The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 31 centers

• Advanced Research Center, Inc — Anaheim
• ATP Clinical Research — Costa Mesa
• National Institute Of Clinical Research — Garden Grove
• Wr Pri Llc — Newport Beach
• SFM Clinical Research LLC — Boca Raton
• Envision Trials LLC — Bonita Springs
• Clinical Research of Brandon — Brandon
• Brain Matters Research — Delray Beach
• … and 23 more centers

Bulgaria · 7 centers

• State Psychiatric Hospital - Lovech — Lovech
• Medical Center Medconsult-Pleven — Pleven
• 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

Czechia · 6 centers

• Fakultni nemocnice u sv. Anny v Brne — Brno
• NEUROHK s r o — Choceň
• Neuroterapie KH S R O — Kutná Hora
• A Shine S R O — Pilsen
• Clintrial s r o — Prague
• NeuropsychiatrieHK, s.r.o. — Prague

Romania · 6 centers

• 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 si Neurologie Brasov — Com Sanpetru
• SC Carpe Diem SRL — Sibiu

Slovakia · 6 centers

• Neurologicka ambulancia MUDr.Dupejova s.r.o. — Banská Bystrica
• Univerzitna nemocnica Bratislava — Bratislava
• Epamed sro — Košice
• NEURES s r o — Krompachy
• Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O. — Svidník
• Crystal Comfort s.r.o. — Vranov nad Topľou

Serbia · 5 centers

• Clinical Center Dr Dragisa Misovic Dedinje — Belgrade
• Institute of Mental Health Serbia — Belgrade
• Special Hospital for Psychiatric Diseases Kovin — Kovin
• University Clinical Center NIS — Niš
• Special Hospital for Psychiatric Diseases Sveti Vracevi — Novi Kneževac

Spain · 5 centers

• Hosp. Gral. de Albacete — Albacete
• Hospital Universitari Germans Trias i Pujol — Badalona
• Hosp. Quirónsalud Málaga — Málaga
• Hosp. Prov. de Zamora — Zamora
• Hosp. Viamed Montecanal — Zaragoza

Croatia · 4 centers

• University Hospital Centre Zagreb 1 — Zagreb
• University Hospital Centre Zagreb — Zagreb
• Psychiatric Clinic "VRAPCE" — Zagreb
• Psychiatric Hospital Sveti Ivan — Zagreb

Identifiers

NCT: NCT06651567 · ITI-1284-101 · ITI-1284-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗