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DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes Phase 3 312 Randomisiert Doppelblind Placebo-kontrolliert

Noch nicht rekrutierend
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Die klinische Studie NCT07241897 untersucht Behandlung im Zusammenhang mit Ischämischer Schlaganfall, Diabetes mellitus. Diese interventionsstudie der Phase 3 hat den Status noch nicht rekrutierend. Der Start ist für 15. Dezember 2025 geplant, bis 312 Teilnehmer aufgenommen werden. Durchgeführt von Second Affiliated Hospital of Soochow University wird der Abschluss für 30. April 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 21. November 2025 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
Ischämischer SchlaganfallDiabetes mellitus
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • LC2024019
  • 82471226 (Andere Zuwendungs-/Finanzierungsnummer) (the National Natural Science Foundation of China)
NCT-Nummer
NCT07241897
Studienbeginn (tatsächlich)
2025-12-15
Zuletzt aktualisiert
2025-11-21
Studienende (vorauss.)
2028-04-30
Geplante Rekrutierung
312
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Noch nicht rekrutierend
Stichwörter
DPP4 inhibitors
Ischemic Stroke
PSCI
Diabetes Mellitus
RCT
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Dreifach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellIntervention 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.
Placebo-VergleichspräparatControl 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
PLACEBO
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Change in MoCA score before and after the 180-day intervention
Change in MoCA score before and after the 180-day intervention
180 days
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
40 Years
Zugelassene Geschlechter
Alle
  1. Mild ischemic stroke, defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.
  2. Coexisting type 2 diabetes with a disease duration of less than 5 years.
  3. Ability to complete the MoCA, MMSE, and the NINDS-CSN-recommended 1-hour standardized neuropsychological test for VCI.
  4. Age between 40 and 75 years.
  5. Onset of stroke within the last 2 weeks.
  6. Glycated hemoglobin (HbA1c) between 6.5% and 8.5%.
  7. More than 9 years of education.
  8. Informed consent signed by the patient or their family.

  1. Coexisting dementia or severe cognitive impairment (MoCA < 17).
  2. Coexisting severe depression, defined as a Hamilton Depression Rating Scale (HAMD) score ≥ 20.
  3. Prior use of cognitive-enhancing drugs, such as donepezil or memantine.
  4. Allergy to DPP4 inhibitors.
  5. Past or current use of DPP4 inhibitors.
  6. Past or current use of GLP-1 agonists.
  7. Type 1 diabetes, latent autoimmune diabetes in adults, secondary diabetes, malignant tumors, autoimmune diseases, or other endocrine-related diseases.
  8. Moderate or severe liver or kidney dysfunction.
  9. Chronic or acute pancreatitis.
  10. Pregnancy or lactation.
  11. Severe infection or severely impaired immune response.
  12. Participation in other clinical trials.
  13. Past or current use of insulin therapy.
Second Affiliated Hospital of Soochow University logoSecond Affiliated Hospital of Soochow University
Verantwortliche Partei
yifang zhu, Hauptprüfer, Professor, Second Affiliated Hospital of Soochow University
Zentrale Studienkontakte
Kontakt: Shoujiang You, MD, PhD, +8615995738506, [email protected]
Kontakt: WenYan Hua, MD, 0512-67783682, [email protected]
1 Studienstandorte in 1 Ländern

Jiangsu

Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215004, China
Shoujiang You, MD, PhD, Kontakt, 00 86 512 67783662, [email protected]
Yongjun Cao, MD, PhD, Kontakt, 00 86 512 67784789, [email protected]