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Efficacy of Lymphatic-Venous Anastomosis Plus Donepezil Versus Donepezil Alone for Alzheimer's Disease

A Multicenter Randomized Controlled Trial on the Efficacy and Safety of Cervical Lymph Vessel/Node-venous Anastomosis Combined With Donepezil Versus Donepezil Alone in the Treatment of Alzheimer's Disease

This study employed a multicenter, randomized controlled trial (RCT) design to evaluate the efficacy and safety of deep cervical lymphatic/lymph node-venous anastomosis combined with oral donepezil compared to donepezil monotherapy in patients with Alzheimer's disease and moderate dementia. Participants were randomized using a central randomization system with stratified block design, with the study center and age group (50-64 years, 65-80 years) as stratification factors. While study participants and surgical investigators could not be blinded due to the nature of the intervention, efficacy assessors and imaging specialists remained blinded to ensure the objectivity and reliability of the findings. The intervention group received deep cervical lymphatic/lymph node-venous anastomosis (detailed surgical procedure is specified in the protocol) in combination with oral donepezil (5-10 mg/day), while the control group received oral donepezil alone. The total treatment and follow-up period was 18 months, with assessments conducted at baseline, 1 week, 1, 3, 6, 12, and 18 months post-operation. These included neuropsychological evaluations (MMSE, MoCA, CDR, BADL, IADL, NPI, AES), neuroimaging (MRI, PET, ultrasound), fluid biomarker analyses (CSF and blood levels of Aβ, Tau, neuroinflammatory factors, etc.), and safety monitoring. The primary efficacy endpoint was the change in CDR-SB score at 12 months post-treatment. Secondary endpoints included changes in multiple cognitive scales, neuroimaging metrics, and biomarkers at 18 months. Safety indicators encompassed adverse event recording, vital signs, and laboratory tests.

Studienübersicht

Studientyp

Interventionell

Einschreibung (Geschätzt)

216

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Ke Li

Studieren Sie die Kontaktsicherung

Studienorte

    • Huangpu
      • Shanghai, Huangpu, China, 200011
        • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
        • Kontakt:
          • Yixin Zhang, MD.
          • Telefonnummer: 5576 +86-21-23271699
          • E-Mail: shjyiec@126.com

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria

  1. The patient or guardian signs the informed consent form;
  2. Age 50-80 years (≥50 years, ≤80 years), male or female;
  3. The first diagnosis is Alzheimer's disease with dementia;
  4. MMSE score ≤24;
  5. Positive β-amyloid protein PET imaging findings;
  6. HAMD score ≤17;
  7. Hachinski score ≤7;
  8. No AD-related drug treatment has been received within the past 1 month;
  9. ASA grade 1-3 (≥ grade 1, ≤ grade 3).
  10. CDR-SB score of 9.5-15.5

Exclusion Criteria

  1. Presence of contraindications to MRI, ICG angiography, or PET scan;
  2. Presence of contraindications to lumbar puncture;
  3. Severe heart disease or unstable hemodynamic status;
  4. Severe lung disease, including severe obstructive, restrictive, or mixed ventilatory dysfunction, or acute inflammation within 3 months;
  5. Hepatic insufficiency, AST or ALT >3 times the upper limit of normal;
  6. Renal insufficiency, GFR <60 mL/min or need for blood purification treatment;
  7. MRI indicates active or acute intracranial lesions, including intracranial infection, space-occupying lesions, major hemorrhage, and ≥4 lobar microbleeds, etc.;
  8. History of cerebral hemorrhage or cerebral infarction with severe residual neurological dysfunction;
  9. Blood diseases, bleeding/coagulation disorders, coagulation dysfunction;
  10. Abnormal thyroid function;
  11. Moderate or severe stenosis of intracranial or cervical vessels with severe residual neurological dysfunction;
  12. Severe hypertension not effectively controlled, systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
  13. The disease requires systemic use of steroids;
  14. Drug addiction (including alcohol, narcotics, and alcohol dependence);
  15. Severe infectious diseases, including HIV positivity, severe infection, etc.;
  16. Severe psychiatric disease or potential suicide risk;
  17. Within 3 years after radical surgery for malignant tumor;
  18. Participation in other interventional clinical trials within the past three months;
  19. In the physician's judgment, poor compliance, inability to complete, or unwillingness to cooperate with regular postoperative follow-up;
  20. Other circumstances that the physician considers unsuitable for this clinical trial.
  21. Anti-Aβ monoclonal antibody treatment has been received within half a year

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil group
Under total intravenous anesthesia, the patient is placed supine with the head turned and shoulders elevated. A transverse neck incision is made, the platysma is opened, and the external jugular vein and great auricular nerve are exposed and protected. Dissection proceeds along the sternocleidomastoid muscle and carotid sheath to create two lymphatic composite flaps: a lateral IIB/III flap rich in deep cervical lymph nodes and lymphatic vessels, and a medial IIA flap containing the angular lymph node. Both flaps are prepared to ensure continuous lymphatic fluid outflow. Revascularization is then performed by end-to-end anastomosis of the IIA flap to a branch of the common facial vein or external jugular vein, and end-to-side anastomosis of the IIB/III flap to the internal or external jugular vein. After the anastomosis is completed, the incision is sutured layer by layer for cosmetic purposes.
After randomly assigned into the group, the study participants were given donepezil orally (the cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil group began to take donepezil orally on the first day after operation, and the oral donepezil group began to take donepezil after completing the baseline examination), once a day, before sleep, starting at 5 mg/day, and adjusted to 10 mg/day after 6 weeks; if not tolerated, it will be maintained at 5 mg/day, continued for 6 weeks, and then 10 mg/day will be attempted again, with continuous administration for 18 months. If research participants still cannot tolerate the high dose, they may be maintained at 5 mg/day for 18 months.
Aktiver Komparator: Oral donepezil group
After randomly assigned into the group, the study participants were given donepezil orally (the cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil group began to take donepezil orally on the first day after operation, and the oral donepezil group began to take donepezil after completing the baseline examination), once a day, before sleep, starting at 5 mg/day, and adjusted to 10 mg/day after 6 weeks; if not tolerated, it will be maintained at 5 mg/day, continued for 6 weeks, and then 10 mg/day will be attempted again, with continuous administration for 18 months. If research participants still cannot tolerate the high dose, they may be maintained at 5 mg/day for 18 months.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 12
Zeitfenster: Baseline and Month 12
The Clinical Dementia Rating-Sum of Boxes is a clinician-rated measure of dementia severity. The score ranges from 0 to 18, with higher scores indicating greater impairment and more severe dementia. The outcome measure is the change from baseline to Month 12. The scale will be administered face to face by trained evaluators blinded to treatment assignment, and results will be reviewed by an independent endpoint adjudication committee.
Baseline and Month 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 18
Zeitfenster: Baseline and Month 18
The Clinical Dementia Rating-Sum of Boxes score ranges from 0 to 18, with higher scores indicating greater dementia severity. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Mini-Mental State Examination Score at Month 18
Zeitfenster: Baseline and Month 18
The Mini-Mental State Examination assesses global cognitive function. The score ranges from 0 to 30, with higher scores indicating better cognitive function. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Montreal Cognitive Assessment Score at Month 18
Zeitfenster: Baseline and Month 18
The Montreal Cognitive Assessment assesses cognitive function. The score ranges from 0 to 30, with higher scores indicating better cognitive function. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in 18-item Apathy Evaluation Scale Score at Month 18
Zeitfenster: Baseline and Month 18
The 18-item Apathy Evaluation Scale assesses apathy symptoms. The total score ranges from 18 to 72, with higher scores indicating more severe apathy. The outcome measure is the change from baseline to Month 18. Assessments will be performed by trained evaluators blinded to treatment assignment.
Baseline and Month 18
Change From Baseline in Neuropsychiatric Inventory Total Score at Month 18
Zeitfenster: Baseline and Month 18
The 12-item Neuropsychiatric Inventory assesses behavioral and psychological symptoms in dementia. For each domain, the domain score is calculated as frequency multiplied by severity. The total score ranges from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Basic Activities of Daily Living Score at Month 18
Zeitfenster: Baseline and Month 18
The Basic Activities of Daily Living score is derived from six items of the Activities of Daily Living scale, including walking, eating, dressing, grooming, bathing, and toileting. Each item is scored from 1 to 4, and the total score ranges from 6 to 24, with higher scores indicating greater impairment in basic self-care ability. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Instrumental Activities of Daily Living Score at Month 18
Zeitfenster: Baseline and Month 18
The Instrumental Activities of Daily Living score is derived from eight items of the Activities of Daily Living scale, including using public transportation, cooking, doing housework, taking medication, doing laundry, shopping, using the telephone, and handling personal finances. Each item is scored from 1 to 4, and the total score ranges from 8 to 32, with higher scores indicating greater impairment in complex daily living ability. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in PET Imaging Measures at Month 18
Zeitfenster: Baseline and Month 18

Positron emission tomography (PET) will be used to assess cerebral amyloid and tau burden:

Amyloid PET: Cerebral amyloid deposition will be quantified using the unitless standardized uptake value ratio (SUVR) and the standardized Centiloid scale. Higher SUVR and Centiloid values indicate greater amyloid deposition.

Tau PET: Cerebral tau deposition will be quantified using the unitless standardized uptake value ratio (SUVR). Higher SUVR values indicate greater tau deposition.

Baseline and Month 18
Change From Baseline in Brain Volumetric MRI Measures at Month 18
Zeitfenster: Baseline and Month 18
Structural brain MRI will be used to measure gray matter volume (GMV), white matter volume (WMV), cerebrospinal fluid volume (CSFV), intracranial volume (ICV), white matter hyperintensity volume (WMHV), hippocampal volume (HippV), and frontal lobe volume (FronV). All volumes will be reported in milliliters (mL). The outcome measures are the changes in these MRI-derived volumes from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Glymphatic System-Related MRI Measures at Month 18
Zeitfenster: Baseline and Month 18
MRI will be used to assess glymphatic system-related measures: perivascular space volume fraction in the whole brain, white matter, and basal ganglia (PVSVF-ALL, PVSVF-WM, and PVSVF-BG); free-water fraction in the whole brain, white matter, and basal ganglia (FW-ALL, FW-WM, and FW-BG); and diffusion tensor imaging analysis along the perivascular space indices for the left hemisphere, right hemisphere, and overall brain (ALPS-L, ALPS-R, and ALPS-ALL). PVSVF and FW are reported as unitless numerical fractions, and the ALPS indices are dimensionless. The outcome measures are the changes in these MRI-derived values from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Internal Jugular Vein Diameter on Ultrasound at Month 18
Zeitfenster: Baseline and Month 18
Ultrasound will be used to measure the diameter of the internal jugular vein in the operative area. The diameter will be reported in millimeters. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in External Jugular Vein Diameter on Ultrasound at Month 18
Zeitfenster: Baseline and Month 18
Ultrasound will be used to measure the diameter of the external jugular vein in the operative area. The diameter will be reported in millimeters. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Maximum Jugular Vein Flow Velocity on Ultrasound at Month 18
Zeitfenster: Baseline and Month 18
Ultrasound will be used to measure the maximum flow velocity of the internal or external jugular vein in the operative area. Flow velocity will be reported in centimeters per second. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Histopathological Findings in Intraoperatively Collected Lymph Node Tissue
Zeitfenster: During surgery
Histopathological findings in lymph node tissue collected intraoperatively, when available, will be assessed using routine histopathological staining.
During surgery
Concentration of Phosphorylated Tau 217 in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of phosphorylated tau 217 (P-tau217) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Amyloid-Beta 42 in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of amyloid-beta 42 (Aβ42) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Phosphorylated Tau 181 in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of phosphorylated tau 181 (P-tau181) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/ml).
During surgery
Concentration of Amyloid-Beta 40 in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of amyloid-beta 40 (Aβ40) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Neurofilament Light Chain in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of neurofilament light chain (NfL) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Glial Fibrillary Acidic Protein in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of glial fibrillary acidic protein (GFAP) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Interleukin-1 Alpha in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of interleukin-1 alpha (IL-1α) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Interleukin-1 Beta in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of interleukin-1 beta (IL-1β) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Interleukin-8 in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of interleukin-8 (IL-8) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Tumor Necrosis Factor Alpha in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of tumor necrosis factor alpha (TNF-α) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Interleukin-12 in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of interleukin-12 (IL-12) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Interleukin-6 in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of interleukin-6 (IL-6) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Interferon Gamma in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of interferon gamma (IFN-γ) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Interleukin-17A in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of interleukin-17A (IL-17A) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Interleukin-4 in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of interleukin-4 (IL-4) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Interleukin-10 in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of interleukin-10 (IL-10) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Interleukin-1 Receptor Antagonist in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of interleukin-1 receptor antagonist (IL-1ra) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Concentration of Transforming Growth Factor Beta in Intraoperatively Collected Lymphatic Fluid
Zeitfenster: During surgery
The concentration of transforming growth factor beta (TGF-β) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
During surgery
Change From Baseline in Cerebrospinal Fluid P-tau181 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of phosphorylated tau 181 (P-tau181) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid Total Tau Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of total tau (T-tau) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid Aβ42 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of amyloid-beta 42 (Aβ42) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid Aβ40 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of amyloid-beta 40 (Aβ40) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid Aβ42/Aβ40 Ratio at Month 18
Zeitfenster: Baseline and Month 18
The ratio of amyloid-beta 42 to amyloid-beta 40 (Aβ42/Aβ40) in cerebrospinal fluid will be reported as a unitless ratio. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid BD-tau Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of brain-derived tau (BD-tau) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid GFAP Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of glial fibrillary acidic protein (GFAP) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid NfL Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of neurofilament light chain (NfL) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid pTau217 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of phosphorylated tau 217 (pTau217) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid IL-1α Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-1 alpha (IL-1α) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid IL-1β Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-1 beta (IL-1β) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid IL-8 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-8 (IL-8) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid TNF-α Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of tumor necrosis factor alpha (TNF-α) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid IL-12 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-12 (IL-12) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid IL-6 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-6 (IL-6) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid IFN-γ Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interferon gamma (IFN-γ) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid IL-17A Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-17A (IL-17A) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid IL-4 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-4 (IL-4) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid IL-10 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-10 (IL-10) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid IL-1ra Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-1 receptor antagonist (IL-1ra) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Cerebrospinal Fluid TGF-β Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of transforming growth factor beta (TGF-β) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma P-tau181 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of phosphorylated tau 181 (P-tau181) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma Total Tau Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of total tau (T-tau) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma Aβ42 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of amyloid-beta 42 (Aβ42) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma Aβ40 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of amyloid-beta 40 (Aβ40) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma Aβ42/Aβ40 Ratio at Month 18
Zeitfenster: Baseline and Month 18
The ratio of amyloid-beta 42 to amyloid-beta 40 (Aβ42/Aβ40) in plasma will be reported as a unitless ratio. The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma BD-tau Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of brain-derived tau (BD-tau) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma GFAP Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of glial fibrillary acidic protein (GFAP) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma NfL Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of neurofilament light chain (NfL) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma pTau217 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of phosphorylated tau 217 (pTau217) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma IL-1α Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-1 alpha (IL-1α) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma IL-1β Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-1 beta (IL-1β) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma IL-8 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-8 (IL-8) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma TNF-α Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of tumor necrosis factor alpha (TNF-α) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma IL-12 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-12 (IL-12) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma IL-6 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-6 (IL-6) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma IFN-γ Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interferon gamma (IFN-γ) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma IL-17A Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-17A (IL-17A) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma IL-4 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-4 (IL-4) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma IL-10 Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-10 (IL-10) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma IL-1ra Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of interleukin-1 receptor antagonist (IL-1ra) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18
Change From Baseline in Plasma TGF-β Level at Month 18
Zeitfenster: Baseline and Month 18
The concentration of transforming growth factor beta (TGF-β) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.
Baseline and Month 18

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juli 2026

Primärer Abschluss (Geschätzt)

30. September 2028

Studienabschluss (Geschätzt)

31. März 2029

Studienanmeldedaten

Zuerst eingereicht

7. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. März 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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