En studie av ONO-2020 hos pasienter med agitasjon assosiert med Alzheimers sykdom demens
24. september 2026 oppdatert av: Ono Pharmaceutical Co., Ltd.
En fase 2A, multisenter, placebokontrollert, randomisert, dobbeltblind, parallellgruppeundersøkelse for å evaluere effektiviteten og sikkerheten til ONO-2020 hos pasienter med agitasjon assosiert med Alzheimers sykdom demens
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
90
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: North America Clinical Trial Support Desk
- Telefonnummer: +18665877745(Toll-Free)
- E-post: clinical_trial@ono-pharma.com
Studer Kontakt Backup
- Navn: International Clinical Trial Support Desk
- Telefonnummer: +17162141777(Standard)
- E-post: clinical_trial@ono-pharma.com
Studiesteder
-
-
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Aichi, Japan
- Rekruttering
- Hotei Hospital
-
Akita, Japan
- Rekruttering
- Akita Prefectural Center For Rehabilitation and Psychiatric Medicine
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Akita, Japan
- Rekruttering
- Medical Corporation Keishinkai Kyowa Hospital
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Aomori, Japan
- Rekruttering
- Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
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Aomori, Japan
- Rekruttering
- Seinan Hospital
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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
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Hiroshima, Japan
- Rekruttering
- Koseikai Cocoro Hospital Kusatsu
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Hiroshima, Japan
- Rekruttering
- Nakamura Hospital
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Hokkaido, Japan
- Rekruttering
- Keiseikai Hospital
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Hokkaido, Japan
- Rekruttering
- NHO Obihiro National Hospital
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Kagoshima, Japan
- Rekruttering
- Ishiki Hospital
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Kagoshima, Japan
- Rekruttering
- Airanomori Hospital
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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
- Avsluttet
- 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
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Nagano, Japan
- Rekruttering
- Jizenkai Ando Hospital
-
Nara, Japan
- Rekruttering
- Nara Medical University Hospital
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Osaka, Japan
- Rekruttering
- Nagaokai Neyagawa Sanatorium
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Osaka, Japan
- Rekruttering
- Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
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Osaka, Japan
- Rekruttering
- Osaka Psychiatric Medical Center
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Saga, Japan
- Rekruttering
- Hizen Psychiatric Center
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Saga, Japan
- Rekruttering
- Rainbow & Sea Hospital
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Saitama, Japan
- Rekruttering
- Saitama Konan Hospital
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Tokyo, Japan
- Avsluttet
- Asuka Hospital
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Tokyo, Japan
- Avsluttet
- Nishigahara Hospital
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Yamagata, Japan
- Rekruttering
- Sanyokai Sanyo Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Two ONO-2020 placebo tablets will be orally administered once daily |
|
Eksperimentell: ONO-2020
|
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Project Leader, Ono Pharmaceutical Co., Ltd.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2025
Primær fullføring (Antatt)
31. desember 2026
Studiet fullført (Antatt)
31. mars 2027
Datoer for studieregistrering
Først innsendt
27. januar 2025
Først innsendt som oppfylte QC-kriteriene
27. januar 2025
Først lagt ut (Faktiske)
31. januar 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ONO-2020-03
- jRCT2041230153 (Registeridentifikator: Japan Registry of Clinical Trials)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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