NCT07854327Toboroz
Restoring Cervical Lymphatic Drainage in Alzheimer's Disease
Evaluating the Effects of Restoring Lymphatic Drainage in Alzheimer's Disease: The LymphDAD Pilot Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.
Rövid összefoglaló (regiszter, angolul)
Alzheimer's disease (AD) is a progressive neurodegenerative disorder associated with the accumulation of abnormal proteins, including amyloid-beta and tau, in the brain. Recent evidence suggests that the glymphatic and meningeal lymphatic systems, which contribute to the removal of waste products from the brain, may play a role in AD. In particular, impaired drainage through the deep cervical lymphatic system may contribute to the accumulation of disease-related proteins. The LymphDAD study is a prospective, single-center pilot study designed to explore whether surgically improving cervical lymphatic drainage may be associated with changes in biological markers, brain imaging, and cognitive and clinical measures in selected patients with AD who are not eligible for currently available disease-modifying treatments. Five participants with AD will undergo a minimally invasive microsurgical procedure called lymphovenous anastomosis (LVA), in which small cervical lymphatic vessels are connected to nearby small veins to facilitate lymphatic drainage. During the procedure, a small sample of lymphatic fluid will also be collected for exploratory analysis of amyloid-beta and tau proteins. Participants will undergo clinical and neuropsychological assessments, blood sampling, magnetic resonance imaging (MRI), and amyloid positron emission tomography (PET) before the procedure and during follow-up. Follow-up assessments will be performed at 1, 3, 6, and 12 months after surgery. The study is exploratory and is not designed to demonstrate a definitive clinical benefit. Its primary purpose is to obtain preliminary information on the feasibility, safety, and possible biological and clinical effects of cervical LVA in AD, which may support the design of future controlled studies.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 5 (tervezett)
- Első benyújtás
- 2026. aug. 19.
- Kezdés
- 2026. júl. 1.
- Elsődleges befejezés
- 2028. júl. 1.
- Fő szponzor
- University of Siena
- Betegségek
- Alzheimer-kór, Frontotemporális demencia
- NCT-szám
- NCT07854327
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 5
- 2026. júl. 1. és az elsődleges befejezés (2028. júl. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Prior extensive cervical lymph node dissection or radiotherapy.
- Participation in another interventional trial within the previous 3 months.
- Evidence of alternative or concomitant causes of cognitive decline other than Alzheimer's disease, such as subdural hematoma, primary or metastatic brain malignancy, or normal-pressure hydrocephalus.
- Current or recent treatment with immunosuppressive or immunomodulatory therapy within the previous 3 months.
- Clinically significant infectious disease within the previous 6 months.
Más betegség
- Coagulopathy or active infection of the head and neck region.
- Uncontrolled systemic disease or contraindication to general anesthesia.
- Known hypersensitivity or allergy to indocyanine green.
- Severe psychiatric disorder that could interfere with cognitive assessment or study participation.
- End-stage malignant disease with an estimated life expectancy of less than 6 months.
- History indicative of systemic autoimmune disease.
Egyéb
- Pregnancy or breastfeeding.
- Inability to personally provide valid informed consent.
Kiket keres a vizsgálat
- Diagnosis of Alzheimer's disease according to NIA-AA 2024 criteria.
- Not eligible for other disease-modifying therapies.
- Ability to personally provide written informed consent after clinical evaluation -of decisional capacity.
Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Le Scotte | Siena | Olaszország | Toboroz |
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