アルツハイマー病に関連する攪拌患者におけるONO-2020の研究
アルツハイマー病の認知症に関連する攪拌患者におけるONO-2020の有効性と安全性を評価するための第2A相2A、多施設、プラセボ対照、無作為化、二重盲検、平行グループ研究
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：North America Clinical Trial Support Desk
- 電話番号：+18665877745(Toll-Free)
- メール：clinical_trial@ono-pharma.com
研究連絡先のバックアップ
- 名前：International Clinical Trial Support Desk
- 電話番号：+17162141777(Standard)
- メール：clinical_trial@ono-pharma.com
研究場所
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Aichi、日本
- 募集
- Hotei Hospital
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Akita、日本
- 募集
- Akita Prefectural Center For Rehabilitation and Psychiatric Medicine
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Akita、日本
- 募集
- Medical Corporation Keishinkai Kyowa Hospital
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Aomori、日本
- 募集
- Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
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Aomori、日本
- 募集
- Seinan Hospital
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Fukui、日本
- 募集
- Fukui Hospital
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Fukui、日本
- 募集
- Matsubara Hospital
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Fukuoka、日本
- 募集
- Kuramitsu Hospital
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Fukuoka、日本
- 募集
- Aburayama Hospital
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Gunma、日本
- 募集
- Kishikai Kishi Hospital
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Hiroshima、日本
- 募集
- Hayakawa Clinic
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Hiroshima、日本
- 募集
- Koseikai Cocoro Hospital Kusatsu
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Hiroshima、日本
- 募集
- Nakamura Hospital
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Hokkaido、日本
- 募集
- Keiseikai Hospital
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Hokkaido、日本
- 募集
- NHO Obihiro National Hospital
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Kagoshima、日本
- 募集
- Ishiki Hospital
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Kagoshima、日本
- 募集
- Airanomori Hospital
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Kagoshima、日本
- 募集
- Sansyu Hospital
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Kagoshima、日本
- 募集
- Taniyama Hospital
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Kanagawa、日本
- 募集
- Hatano Kousei Hospital
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Kanagawa、日本
- 募集
- Fujisawahospital
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Kanagawa、日本
- 募集
- Showa Medical University Northern Yokohama Hospital
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Kochi、日本
- 募集
- Hosogi Hospital
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Kochi、日本
- 終了しました
- Ichiyo Mental Hospital
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Kyoto、日本
- 募集
- Maizuru Medical Center
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Kyoto、日本
- 募集
- Nishiyama Hospital
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Miyagi、日本
- 募集
- Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba
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Nagano、日本
- 募集
- JA-Nagano North Alps Medical Center Azumi Hospital
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Nagano、日本
- 募集
- Jizenkai Ando Hospital
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Nara、日本
- 募集
- Nara Medical University Hospital
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Osaka、日本
- 募集
- Nagaokai Neyagawa Sanatorium
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Osaka、日本
- 募集
- Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
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Osaka、日本
- 募集
- Osaka Psychiatric Medical Center
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Saga、日本
- 募集
- Hizen Psychiatric Center
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Saga、日本
- 募集
- Rainbow & Sea Hospital
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Saitama、日本
- 募集
- Saitama Konan Hospital
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Tokyo、日本
- 終了しました
- Asuka Hospital
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Tokyo、日本
- 終了しました
- Nishigahara Hospital
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Yamagata、日本
- 募集
- Sanyokai Sanyo Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
|
Two ONO-2020 placebo tablets will be orally administered once daily |
|
実験的：オノ-2020
|
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in CMAI score from baseline
時間枠：up to week 12
|
To assess agitation symptoms |
up to week 12
|
|
Adverse events
時間枠：up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
Body weight
時間枠：up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
Body temperature
時間枠：up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
Blood pressure
時間枠：up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
Pulse rate
時間枠：up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
Respiratory rate
時間枠：up to week 16
|
To Evaluate the Safety |
up to week 16
|
|
ECG RR interval
時間枠：up to week 12
|
To Evaluate the Safety |
up to week 12
|
|
ECG PR interval
時間枠：up to week 12
|
To Evaluate the Safety |
up to week 12
|
|
ECG QRS complex
時間枠：up to week 12
|
To Evaluate the Safety |
up to week 12
|
|
ECG QT interval
時間枠：up to week 12
|
To Evaluate the Safety |
up to week 12
|
|
ECG QTcF
時間枠：up to week 12
|
To Evaluate the Safety |
up to week 12
|
|
Number of participants with abnormal laboratory tests (hematology)
時間枠：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)
時間枠：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))
時間枠：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
時間枠：up to week 12
|
Urinalysis (pH, Glucose, Protein, Blood, Ketones) |
up to week 12
|
|
COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS）
時間枠：up to week 16
|
To Evaluate the Safety |
up to week 16
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：up to 12 week
|
To Evaluate the Efficacy |
up to 12 week
|
|
Pharmacokinetic assessments
時間枠：up to 12 week
|
Plasma ONO-2020 concentrations |
up to 12 week
|
協力者と研究者
捜査官
- スタディディレクター：Project Leader、Ono Pharmaceutical Co., Ltd.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ONO-2020-03
- jRCT2041230153 (レジストリ識別子：Japan Registry of Clinical Trials)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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