試験ID jRCTs042260003
最終情報更新日：2026年6月6日
認知機能簡易測定ツール「CQ test」の有効性および妥当性に関する検討
基本情報
| 試験ID | jRCTs042260003 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | 認知機能簡易測定ツール「CQ test」の有効性および妥当性に関する検討 | Validation of the clinical utility and psychometric properties of the digital cognitive assessment tool 'CQ test' in older Adults |
| 平易な研究名称 / Public Title（Acronym） | Study to evaluate the accuracy and usefulness of the digital cognitive test 'CQ test' in older Adults | |
| 試験進捗状況/Recruitment status | Pending | |
| 登録日時 | 2026年4月9日 | |
| 最終情報更新日 | 2026年6月6日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | ||
試験概要
| 試験実施地域 / Region | 日本 | |
|---|---|---|
| 実施都道府県 | 愛知県 | |
| 目標症例数/Target sample size | 100 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | 軽度認知障害または認知症を呈する神経変性疾患 | Mild cognitive impairment and dementia due to neurodegenerative diseases |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | ||
| ランダム化 / Randomization | ||
| 主要評価項目 / Primary outcomes | CQ testの総スコアとMMSEの総スコアとの相関。 | Correlation between the total CQ test score and the MMSE total score. |
| 副次評価項目 / Secondary outcomes | ① CQ testの総スコアとMMSE、MoCA-J、およびACE-Rの総スコアとの相関。 ②MMSE、MoCA-J、ACE-Rと比較した、軽度認知障害（MCI）および早期認知症の検出におけるCQ testの感度および特異度（特に天井効果領域における判別能の評価）。 ③ CQ testによる認知機能検査時間（平均応答時間、正答率調整反応時間処理速度等含む）。 ④ 検査者に対するCQ testの使用評価調査 ⑤ 被験者に対するCQ testに関するアンケート調査（負担の軽減等） ⑥ CQ testの下位項目における認知機能スコアとそれに対するMMSEの下位項目における認知機能スコアとの相関性 ⑦ MMSEの認知機能スコア区分ごとのCQ testによる認知機能スコアとMMSE による認知機能スコアとの相関性 | 1. Correlation between total CQ test score and total scores of MMSE, MoCA-J, and ACE-R. 2. Sensitivity and specificity of CQ test for detecting MCI and early dementia compared with MMSE, MoCA-J, and ACE-R. 3. Assessment time and performance metrics of CQ test. 4. Examiner usability evaluation of CQ test. 5. Participant questionnaire on burden and usability. 6. Correlation between CQ test domain subscores and MMSE domain subscores. 7. Correlation between CQ test and MMSE scores stratified by MMSE severity categories. |
適格性
| 年齢（下限）/ Age minimum | 60歳以上 | >= 60age old |
|---|---|---|
| 年齢（上限）/ Age maximum | Not applicable | |
| 性別 / Gender | 男女両方 | Both |
| 選択基準 / Include criteria | Participants who meet all of the following criteria will be eligible for inclusion in this study. 1. Written informed consent has been obtained from the participant after providing sufficient explanation and ensuring adequate understanding, based on the participant's own free will. 2. Individuals aged 60 years or older (regardless of gender) at the time of obtaining consent. 3. Research subjects must meet one of the following conditions at the time of enrollment: - Individuals who have visited (initial or follow-up) the dementia outpatient clinic (Neurology or Dementia/Geriatrics) at Fujita Health University Hospital and have been diagnosed with, or are suspected of having, mild cognitive impairment (MCI) or dementia. - Healthy elderly people living in the community who have no subjective cognitive decline that interferes with daily life and no history of neurodegenerative disease. 4. Regardless of the use of corrective devices such as glasses or hearing aids, participants must be able to operate digital devices such as tablet terminals required for the CQ test and must have sufficient visual, auditory, and upper limb motor function to recognize and respond to test stimuli. 5. No significant change in health status within 4 weeks prior to enrollment, and judged to be medically stable. 6. If receiving cognitive-enhancing drugs such as cholinesterase inhibitors or psychotropic medications, the dosage and regimen must have been stable for at least 3 months prior to enrollment. otropic medications, the dosage and regimen must have been stable for at least 3 months prior to enrollment. | |
| 除外基準 / Exclude criteria | Participants who meet any of the following criteria will be excluded from the study: 1. Individuals with severe visual, auditory, or upper limb motor impairment that makes it difficult to operate digital devices or to understand the study procedures. 2. Individuals with a history of central nervous system disorders other than the target disease that may significantly affect cognitive function (e.g., brain tumors, traumatic brain injury, acute stroke). 3. Individuals with poorly controlled major psychiatric disorders that may affect cognitive assessment. 4. Individuals with a history of alcohol or illicit drug abuse within the past 6 months, or those using medications that may significantly affect cognitive function or level of consciousness. 5. Individuals currently participating in other interventional studies or cognitive research that may influence cognitive function or study outcomes. 6. Individuals deemed inappropriate for participation by the principal investigator or sub-investigators for any other reason. |
責任研究者
| 責任研究者 / Name of lead principal investigator | Watanabe Hirohisa | |
|---|---|---|
| 組織名 / Organization | ||
| 部署名 / Division | Fujita Health University Hospital | |
| 住所 / Address | 1-98 Dengakugakugo, Kutsukake-cho, Toyoake, Aichi Aichi Japan 470-1192 | |
| 電話 / Telephone | +81-562-93-2111 | |
| 実施責任組織 / Affiliation | 渡辺 宏久 | Fujita Health University Hospital |
| 研究費提供組織 / Funding Source | ||
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | 1-98 Dengakugakugo, Kutsukake-cho, Toyoake, Aichi Aichi Japan 470-1192 | |
|---|---|---|
| 電話 / Telephone | +81-562-93-9295 | |
| ホームページURL | ||
| hirohisa.watanabe@fujita-hu.ac.jp | ||
| 担当者 / Name of contact person | Hirohisa Watanabe |
倫理審査委員会
| 認定臨床研究審査委員会又は倫理審査委員会の名称 | ||
|---|---|---|
| 上記委員会の認定番号 | 住所 / Address | |
| 電話番号 | ||
| 審査受付番号 | ||
| 当該臨床研究に対する審査結果 | ||
| 認定臨床研究審査委員会の承認日 | ||
変更・中止の場合
| 中止届出日 | ||
|---|---|---|
| 中止年月日 | ||
| 中止の理由 | ||
終了の場合
| 終了届出日 | ||
|---|---|---|
| 観察期間終了日 | ||
| 実施症例数 | ||
| 参加者の流れ（Participant flow） | ||
| 研究対象者の背景情報 | ||
| 疾病等の発生状況のまとめ | ||
| 主要評価項目及び副次評価項目のデータ解析及び結果 | ||
| 公開予定日 | ||
| 要約 | ||
| 研究実施計画書のURL | ||
| 結果に関する最初の出版物での発表日 | ||
| 結果と出版物に関するURL | ||
IPD data sharing
| 個々の研究対象者単位のデータ（IPD）を共有する計画 | ||
|---|---|---|
| 計画の説明 | ||