| 基本情報/Basic information |
| 一般向け試験名/Public title |
レビー小体型認知症の患者・介護者・医師の治療ニーズに関する研究 |
Research on the treatment needs of patients with dementia with Lewy bodies, their caregivers, and their physicians |
| 一般向け試験名略称/Acronym |
レビー小体型認知症の患者・介護者・医師の治療ニーズに関する研究 |
Research on the treatment needs of patients with dementia with Lewy bodies, their caregivers, and their physicians |
| 科学的試験名/Scientific Title |
レビー小体型認知症の患者・介護者・医師の治療ニーズに関する研究 |
Research on the treatment needs of patients with dementia with Lewy bodies, their caregivers, and their physicians |
| 科学的試験名略称/Scientific Title:Acronym |
レビー小体型認知症の患者・介護者・医師の治療ニーズに関する研究 |
Research on the treatment needs of patients with dementia with Lewy bodies, their caregivers, and their physicians |
| 試験実施地域/Region |
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| 目的/Objectives |
| 目的1/Narrative objectives1 |
DLB患者、介護者の治療ニーズと、医師による患者、介護者の治療ニーズの理解に関する調査を行い、医師と患者・介護者間の治療ニーズの相違を明らかにし、相違があった場合はその要因を分析する。また、医師間や診療科間でのDLBの症状の着眼点や治療優先順位の相違を把握し、相違があった場合はその要因を分析する。 |
The objective is to conduct research related to the treatment needs of DLB patients and their caregivers, as well as physicians' understanding of those treatment needs. Then, the researchers will identify discrepancies in treatment needs between physician and patients/caregivers. In the event of a discrepancy, the researchers will analyze the cause. In addition, the researchers will gain an understanding of the differences in focus and treatment priorities for DLB symptoms among physicians and clinical departments and analyze the factors that contribute to such differences.
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| 目的2/Basic objectives2 |
その他/Others |
| 目的2 -その他詳細/Basic objectives -Others |
非介入観察研究 |
Non-interventional observational study
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| 試験の性質1/Trial characteristics_1 |
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| 試験の性質2/Trial characteristics_2 |
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| 試験のフェーズ/Developmental phase |
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| 介入/Intervention |
| 群数/No. of arms |
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| 介入の目的/Purpose of intervention |
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| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
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| 介入2/Interventions/Control_2 |
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| 介入3/Interventions/Control_3 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
主治医の選択基準：研究開始時点でDLB患者を診療している主治医であり、かつ以下のいずれかの基準に該当する医師
1) DLB研究会世話人及びその世話人が所属する医療機関の医師
2) DLBサポートネットワークの顧問医・協力医及びその医師が所属する医療機関の医師
3) DLBに関する総説もしくは研究論文を執筆したことのある医師及びその医師が所属する医療機関の医師
患者の選択基準：
1) DLBの臨床診断基準(2017) でprobable LBDを満たし、主治医が3ヵ月以上診療を継続している50歳以上の外来通院している患者
2) 本研究について文書により十分説明を受け、本人または代諾者の自由意思により文書で同意が得られた患者
3) 本研究の参加に関して文書にて同意が得られた介護者がいる患者
介護者の選択基準：
1) 主介護者（患者の介護を主体で担っている介護者の方）
2) 20歳以上の方
3) 本研究について文書により十分説明を受け、自由意思により文書で同意を得られた介護者（同居・別居は問わない）
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Inclusion criteria for physicians:
Attending physicians who are treating DLB patients at the start of the research who also meet any of the following criteria
1) Dementia with Lewy Bodies Society members and physicians of the medical institution to which the member of the group belongs
2) Chief medical adviser/medical adviser of Dementia with Lewy Bodies Support Network or physicians of the medical institution to which the chief medical adviser/medical adviser belongs
3) Physicians who have written review articles or research papers on DLB and physicians of medical institutions to which said physicians belong
Inclusion criteria for patients:
1) Patients who meet probable DLB according to the clinical diagnostic criteria for DLB (2017) and are outpatients over the age of 50 who have been treated by their attending physicians for 3 months or longer.
2) Patients who were fully informed about this research in writing and who have given their informed consent in writing at their or their representative's discretion.
3) Patients with caregivers who have given informed consent to participate in this research
Inclusion criteria for caregivers
1) Main caregiver (caregiver who primarily takes care of the patient)
2) 20 years of age or older.
3) Caregivers who were fully informed about this research in writing and who have given their informed consent in writing (whether living together or separately with patients)
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| 除外基準/Key exclusion criteria |
患者の除外基準：
1) 認知症を伴うパーキンソン病患者【Parkinson’s disease dementia（PDD）：パーキンソニズムが認知症より1年以上先行して出現した疾患と定義】
2) 主治医が同意取得前に3ヵ月を超えて経過をフォローできていない患者
3) 本研究開始前4週間以内に他の治験薬や臨床研究薬の投与を受けた患者、同意取得までに他の治験や臨床研究が終了していない患者
4) 主治医が本臨床研究の対象として不適当と判断した患者
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Exclusion criteria for patients:
1) Patients with Parkinson's disease with dementia [Parkinson's disease dementia (PDD): Defined as a disease in which Parkinsonism appears more than one year before dementia]
2) Patients who have not been followed up by attending physicians for more than 3 months before their informed consent
3) Patients who received other investigational drugs or clinical research drugs within 4 weeks before the start of this research or patients who have not completed other clinical trials or clinical studies at the time of signing their informed consent.
4) Patients judged by attending physicians as inappropriate for this research
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| 目標参加者数/Target sample size |
700 |
UMIN-CTR 臨床試験登録情報の閲覧