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Die klinische Studie NCT06530732 für Alzheimer-Krankheit ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study) Phase 3 60

Offene Rekrutierung
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Die klinische Studie NCT06530732 untersucht Behandlung im Zusammenhang mit Alzheimer-Krankheit. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 1. Juli 2024. Es ist geplant, 60 Teilnehmer aufzunehmen. Durchgeführt von Zhejiang Provincial People's Hospital wird der Abschluss für 30. September 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 16. Januar 2025 aktualisiert.
Kurzbeschreibung
The goal of this clinical trial is to To demonstrate the Safety and Efficacy of dcLVA Surgery for the Treatment of Alzheimer's Disease. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone)

Participants will:

Undergo cogn...

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Ausführliche Beschreibung
This study aims to enroll patients diagnosed with AD. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone). Following randomization, patients will undergo cognitive and brain MRI assessments, a lumbar puncture, and an inje...Mehr anzeigen
Offizieller Titel

Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)

Erkrankungen
Alzheimer-Krankheit
Weitere Studien-IDs
  • KY2024106
NCT-Nummer
NCT06530732
Studienbeginn (tatsächlich)
2024-07-01
Zuletzt aktualisiert
2025-01-16
Studienende (vorauss.)
2026-09-30
Geplante Rekrutierung
60
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Experimentellexperimental group
receiving dcLVA surgery plus standard medication
Deep Cervical lymphatlc-Venous Anastomosis Surgery
Cervical deep lymphatic-venous anastomosis (dcLVA) can promote the flow of cerebrospinal fluid within the glymphatic system. The procedure involves connecting deep cervical lymphatic vessels to veins, reducing pressure on lymph nodes and allowing lymphatic fluid from high-pressure vessels to flow into the lower-pressure venous system. This surgical intervention enhances the clearance of waste in the glymphatic system...Mehr anzeigen
Lecanemab
The newly approved anti-beta-amyloid (Aβ) monoclonal antibody Lecanemab can delay AD progression but is only suitable for patients in the early stages. For those with moderate to severe AD, Lecanemab is not effective.
Aktives Vergleichspräparatcontrol group
receiving standard medication alone
Lecanemab
The newly approved anti-beta-amyloid (Aβ) monoclonal antibody Lecanemab can delay AD progression but is only suitable for patients in the early stages. For those with moderate to severe AD, Lecanemab is not effective.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
The rate of change in the total score of the Clinical Dementia Rating Scale
The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline , using the Chinese version of the CDR scale, with a score range of 0-3 points for each item.The total score ranges from a minimum of 0 points to a maximum of 18 points, where a higher score indicates a worse outcome.
Time Frame: baseline,7 days post-surgery,3-month,6-month and 12-month
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Zugelassene Geschlechter
Alle
  • Diagnosed as an AD patient according to biological markers and clinical symptoms;
  • Over 35 years old and with an MMSE or MOCA score ≤ 26;
  • The patient or family member has signed an informed consent form.

  • Inability to cooperate with lumbar puncture;
  • Cognitive impairment due to neurological infections (e.g., HIV, neurosyphilis, autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction);
  • Significant organ dysfunction (heart, lung, liver, kidney);
  • Coagulation disorders or contraindications to surgery;
  • Inability to fully cooperate with follow-up visits.
Zhejiang Provincial People's Hospital logoZhejiang Provincial People's Hospital
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern

Zhejiang

Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, China
Sheng Zhang, Kontakt, +8618758188313, [email protected]
Sheng Zhang, Hauptprüfer
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