En undersøgelse af ONO-2020 hos patienter med agitation forbundet med Alzheimers sygdom demens
24. september 2026 opdateret af: Ono Pharmaceutical Co., Ltd.
En fase 2a, multicenter, placebokontrolleret, randomiseret, dobbeltblind, parallel-gruppeundersøgelse for at evaluere effektiviteten og sikkerheden af ONO-2020 hos patienter med agitation forbundet med Alzheimers sygdom demensdemensdemensiering
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
90
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: North America Clinical Trial Support Desk
- Telefonnummer: +18665877745(Toll-Free)
- E-mail: clinical_trial@ono-pharma.com
Undersøgelse Kontakt Backup
- Navn: International Clinical Trial Support Desk
- Telefonnummer: +17162141777(Standard)
- E-mail: clinical_trial@ono-pharma.com
Studiesteder
-
-
-
Aichi, Japan
- Rekruttering
- Hotei Hospital
-
Akita, Japan
- Rekruttering
- Akita Prefectural Center For Rehabilitation and Psychiatric Medicine
-
Akita, Japan
- Rekruttering
- Medical Corporation Keishinkai Kyowa Hospital
-
Aomori, Japan
- Rekruttering
- Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
-
Aomori, Japan
- Rekruttering
- Seinan Hospital
-
Fukui, Japan
- Rekruttering
- Fukui Hospital
-
Fukui, Japan
- Rekruttering
- Matsubara Hospital
-
Fukuoka, Japan
- Rekruttering
- Kuramitsu Hospital
-
Fukuoka, Japan
- Rekruttering
- Aburayama Hospital
-
Gunma, Japan
- Rekruttering
- Kishikai Kishi Hospital
-
Hiroshima, Japan
- Rekruttering
- Hayakawa Clinic
-
Hiroshima, Japan
- Rekruttering
- Koseikai Cocoro Hospital Kusatsu
-
Hiroshima, Japan
- Rekruttering
- Nakamura Hospital
-
Hokkaido, Japan
- Rekruttering
- Keiseikai Hospital
-
Hokkaido, Japan
- Rekruttering
- NHO Obihiro National Hospital
-
Kagoshima, Japan
- Rekruttering
- Ishiki Hospital
-
Kagoshima, Japan
- Rekruttering
- Airanomori Hospital
-
Kagoshima, Japan
- Rekruttering
- Sansyu Hospital
-
Kagoshima, Japan
- Rekruttering
- Taniyama Hospital
-
Kanagawa, Japan
- Rekruttering
- Hatano Kousei Hospital
-
Kanagawa, Japan
- Rekruttering
- Fujisawahospital
-
Kanagawa, Japan
- Rekruttering
- Showa Medical University Northern Yokohama Hospital
-
Kochi, Japan
- Rekruttering
- Hosogi Hospital
-
Kochi, Japan
- Afsluttet
- Ichiyo Mental Hospital
-
Kyoto, Japan
- Rekruttering
- Maizuru Medical Center
-
Kyoto, Japan
- Rekruttering
- Nishiyama Hospital
-
Miyagi, Japan
- Rekruttering
- Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba
-
Nagano, Japan
- Rekruttering
- JA-Nagano North Alps Medical Center Azumi Hospital
-
Nagano, Japan
- Rekruttering
- Jizenkai Ando Hospital
-
Nara, Japan
- Rekruttering
- Nara Medical University Hospital
-
Osaka, Japan
- Rekruttering
- Nagaokai Neyagawa Sanatorium
-
Osaka, Japan
- Rekruttering
- Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
-
Osaka, Japan
- Rekruttering
- Osaka Psychiatric Medical Center
-
Saga, Japan
- Rekruttering
- Hizen Psychiatric Center
-
Saga, Japan
- Rekruttering
- Rainbow & Sea Hospital
-
Saitama, Japan
- Rekruttering
- Saitama Konan Hospital
-
Tokyo, Japan
- Afsluttet
- Asuka Hospital
-
Tokyo, Japan
- Afsluttet
- Nishigahara Hospital
-
Yamagata, Japan
- Rekruttering
- Sanyokai Sanyo Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosis of probable AD according to the diagnostic criteria for AD dementia (NIA-AA 2011)
- Mini-Mental State Examination (MMSE) score ≥ 5 to ≤ 22 at the start of the treatment period
- Symptoms of agitation defined by the IPA from at least 14 days before the start of the screening period
- Neuropsychiatric Inventory-Nursing Home version (NPI-NH) Agitation/Aggression domain (NPI-NH-A/A) score ≥ 4 at the start of the treatment period.
- Patients who can participate in the study under hospitalization from 21 days before the start of the treatment period to throughout the treatment period
Exclusion Criteria:
- Diagnosis of dementia not due to AD or any other disorder with memory impairment, such as mixed dementia, vascular dementia, Lewy body dementia, dementia associated with Parkinson's disease, frontotemporal dementia, drug-induced dementia, dementia associated with human immunodeficiency virus (HIV) infection, traumatic brain injury, normal pressure hydrocephalus, or other non-AD dementia
- Any MRI or CT scan of the brain performed after the onset of dementia with findings consistent with clinically relevant CNS disease other than AD, such as vascular changes (eg, cortical cerebral infarction, multiple cerebral infarctions), space-occupying lesions (eg, tumors), or any other major structural brain disease
- Delirium within 30 days before the start of the screening period or a history of delirium
- At risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) (answers "yes" to Question 4 or 5 of the suicidal ideation section of the C-SSRS) or any suicide attempt within 6 months before the start of the screening period, or at serious risk of suicide in the opinion of the investigator or subinvestigator
- Prior or current treatment with anti-amyloid beta antibodies
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Two ONO-2020 placebo tablets will be orally administered once daily |
|
Eksperimentel: ONO-2020
|
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in CMAI score from baseline
Tidsramme: up to week 12
|
To assess agitation symptoms |
up to week 12
|
|
Adverse events
Tidsramme: up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
Body weight
Tidsramme: up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
Body temperature
Tidsramme: up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
Blood pressure
Tidsramme: up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
Pulse rate
Tidsramme: up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
Respiratory rate
Tidsramme: up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
ECG RR interval
Tidsramme: up to week 12
|
To Evaluate the Safety |
up to week 12
|
|
ECG PR interval
Tidsramme: up to week 12
|
To Evaluate the Safety |
up to week 12
|
|
ECG QRS complex
Tidsramme: up to week 12
|
To Evaluate the Safety |
up to week 12
|
|
ECG QT interval
Tidsramme: up to week 12
|
To Evaluate the Safety |
up to week 12
|
|
ECG QTcF
Tidsramme: up to week 12
|
To Evaluate the Safety |
up to week 12
|
|
Number of participants with abnormal laboratory tests (hematology)
Tidsramme: up to week 12
|
Hematology (PT, RBC count, RBC indices, WBC count, Differential, Hemoglobin, Hematocrit) |
up to week 12
|
|
Number of participants with abnormal laboratory tests (Clinical chemistry)
Tidsramme: up to week 12
|
Clinical chemistry (Blood urea nitrogen (BUN), Potassium, Creatinine, Sodium, Glucose (fasting or nonfasting), Calcium, Chloride, Total protein, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase, Total and direct bilirubin, Lactate dehydrogenase (LDH), Phospholipid, γ-Glutamyl transferase (GGT) |
up to week 12
|
|
Number of participants with abnormal Blood coagulation profile (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))
Tidsramme: up to week 12
|
Blood coagulation (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR)) |
up to week 12
|
|
Number of participants with abnormal Urinalysis
Tidsramme: up to week 12
|
Urinalysis (pH, Glucose, Protein, Blood, Ketones) |
up to week 12
|
|
COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS）
Tidsramme: up to week 16
|
To Evaluate the Safety |
up to week 16
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline
Tidsramme: up to 12 week
|
To Evaluate the Efficacy The range of CMAI score is 29-203. Higher score means a worse outcome. |
up to 12 week
|
|
Clinical Global Impression-Severity （CGI-S） score at each visit and change from baseline
Tidsramme: up to 12 week
|
To Evaluate the Efficacy The range of CGI-S score is 0-7. Higher score means a worse outcome. |
up to 12 week
|
|
Clinical Global Impression-Severity （CGI-S） score at each visit
Tidsramme: up to 12 week
|
To Evaluate the Efficacy |
up to 12 week
|
|
Neuropsychiatric Inventory in Nursing Home Version（NPI-NH） score at each visit and change from baseline
Tidsramme: up to 12 week
|
To Evaluate the Efficacy The range of NPI-NH score is 0-170. Higher score means a worse outcome. |
up to 12 week
|
|
Mini Mental State Exam(MMSE) score at baseline and Week 12, and change from baseline
Tidsramme: up to 12 week
|
To Evaluate the Efficacy The range of MMSE score is 0-30. Higher score means a better outcome. |
up to 12 week
|
|
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)score at baseline and Week 12, and change from baseline
Tidsramme: up to 12 week
|
To Evaluate the Efficacy The range of ADCS-ADL score is 0-78. Higher score means a better outcome. |
up to 12 week
|
|
Duration of the investigational medicinal product administration
Tidsramme: up to 12 week
|
To Evaluate the Efficacy |
up to 12 week
|
|
Pharmacokinetic assessments
Tidsramme: up to 12 week
|
Plasma ONO-2020 concentrations |
up to 12 week
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Project Leader, Ono Pharmaceutical Co., Ltd.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2025
Primær færdiggørelse (Anslået)
31. december 2026
Studieafslutning (Anslået)
31. marts 2027
Datoer for studieregistrering
Først indsendt
27. januar 2025
Først indsendt, der opfyldte QC-kriterier
27. januar 2025
Først opslået (Faktiske)
31. januar 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ONO-2020-03
- jRCT2041230153 (Registry Identifier: Japan Registry of Clinical Trials)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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