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治験 NCT07241897（対象：虚血性脳卒中、糖尿病）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes 第III相・フェーズ3 312 無作為化 二重盲検 プラセボ対照
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07241897 は 治療 の研究で、虚血性脳卒中、糖尿病 に関するものです。この 第III相・フェーズ3 介入研究 臨床試験 は現在 募集準備中 で、2025年12月15日 に開始予定です。312 名の参加者 の募集が計画されています。この試験は Second Affiliated Hospital of Soochow University によって主導され、2028年4月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月21日 です。
概要
Post-stroke cognitive impairment (PSCI) increases the risk of disability and mortality in stroke patients, thereby exacerbating the disease burden of stroke. Type 2 diabetes is a major risk factor for PSCI, and stroke patients with type 2 diabetes have a higher risk of developing PSCI. Despite the high incidence and severe impact of PSCI, effective intervention methods are still lacking. Identifying safe and effectiv...もっと見る
公式タイトル
DPP4 Inhibitor on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes Mellitus (DISC-DM): Multicentre, Double Blind, Randomised, Placebo Controlled Trial
疾患名
虚血性脳卒中糖尿病刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- LC2024019
- 82471226 (その他の助成金/資金番号) (the National Natural Science Foundation of China)
NCT番号
開始日
2025-12-15
最終更新日
2025-11-21
終了予定日
2028-04-30
目標参加者数
312
試験の種類
介入研究
治験の相・段階
第III相・フェーズ3
状況
募集準備中
キーワード
DPP4 inhibitors
Ischemic Stroke
PSCI
Diabetes Mellitus
RCT
Ischemic Stroke
PSCI
Diabetes Mellitus
RCT
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
三重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Intervention Group Sentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. | Sentagliptin Phosphate - single dose Sentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. |
プラセボ対照薬Control Group Placebo (identical in size, shape, color, appearance, and odor to Sentagliptin Phosphate, 50 mg, once daily) plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed | プラセボ Placebo (identical in size, shape, color, appearance, and odor to Sentagliptin Phosphate, 50 mg, once daily) plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in MoCA score before and after the 180-day intervention | Change in MoCA score before and after the 180-day intervention | 180 days |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
PSCI incidence at 180 days | MoCA score \< 25 | 180 days |
Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention | Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention | 180 days |
Changes in MoCA and MMSE scores before and after the 90-day intervention | Changes in MoCA and MMSE scores before and after the 90-day intervention | 90 days |
Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days | Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days | 90 days and 180 days |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
40 Years
対象性別
全て
- Mild ischemic stroke, defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.
- Coexisting type 2 diabetes with a disease duration of less than 5 years.
- Ability to complete the MoCA, MMSE, and the NINDS-CSN-recommended 1-hour standardized neuropsychological test for VCI.
- Age between 40 and 75 years.
- Onset of stroke within the last 2 weeks.
- Glycated hemoglobin (HbA1c) between 6.5% and 8.5%.
- More than 9 years of education.
- Informed consent signed by the patient or their family.
- Coexisting dementia or severe cognitive impairment (MoCA < 17).
- Coexisting severe depression, defined as a Hamilton Depression Rating Scale (HAMD) score ≥ 20.
- Prior use of cognitive-enhancing drugs, such as donepezil or memantine.
- Allergy to DPP4 inhibitors.
- Past or current use of DPP4 inhibitors.
- Past or current use of GLP-1 agonists.
- Type 1 diabetes, latent autoimmune diabetes in adults, secondary diabetes, malignant tumors, autoimmune diseases, or other endocrine-related diseases.
- Moderate or severe liver or kidney dysfunction.
- Chronic or acute pancreatitis.
- Pregnancy or lactation.
- Severe infection or severely impaired immune response.
- Participation in other clinical trials.
- Past or current use of insulin therapy.
Second Affiliated Hospital of Soochow University責任者
yifang zhu, 主任研究者, Professor, Second Affiliated Hospital of Soochow University
試験中央連絡先
連絡先: Shoujiang You, MD, PhD, +8615995738506, [email protected]
連絡先: WenYan Hua, MD, 0512-67783682, [email protected]
1 1カ国の場所
Jiangsu
Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215004, China
Shoujiang You, MD, PhD, 連絡先, 00 86 512 67783662, [email protected]
Yongjun Cao, MD, PhD, 連絡先, 00 86 512 67784789, [email protected]