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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
216
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Ke Li
研究連絡先のバックアップ
- 名前:Yixin Zhang
- 電話番号:+86 13061775858
- メール:zhangyixin6688@163.com
研究場所
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Huangpu
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Shanghai、Huangpu、中国、200011
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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コンタクト:
- Yixin Zhang, MD.
- 電話番号:5576 +86-21-23271699
- メール:shjyiec@126.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria
- The patient or guardian signs the informed consent form;
- Age 50-80 years (≥50 years, ≤80 years), male or female;
- The first diagnosis is Alzheimer's disease with dementia;
- MMSE score ≤24;
- Positive β-amyloid protein PET imaging findings;
- HAMD score ≤17;
- Hachinski score ≤7;
- No AD-related drug treatment has been received within the past 1 month;
- ASA grade 1-3 (≥ grade 1, ≤ grade 3).
- CDR-SB score of 9.5-15.5
Exclusion Criteria
- Presence of contraindications to MRI, ICG angiography, or PET scan;
- Presence of contraindications to lumbar puncture;
- Severe heart disease or unstable hemodynamic status;
- Severe lung disease, including severe obstructive, restrictive, or mixed ventilatory dysfunction, or acute inflammation within 3 months;
- Hepatic insufficiency, AST or ALT >3 times the upper limit of normal;
- Renal insufficiency, GFR <60 mL/min or need for blood purification treatment;
- MRI indicates active or acute intracranial lesions, including intracranial infection, space-occupying lesions, major hemorrhage, and ≥4 lobar microbleeds, etc.;
- History of cerebral hemorrhage or cerebral infarction with severe residual neurological dysfunction;
- Blood diseases, bleeding/coagulation disorders, coagulation dysfunction;
- Abnormal thyroid function;
- Moderate or severe stenosis of intracranial or cervical vessels with severe residual neurological dysfunction;
- Severe hypertension not effectively controlled, systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
- The disease requires systemic use of steroids;
- Drug addiction (including alcohol, narcotics, and alcohol dependence);
- Severe infectious diseases, including HIV positivity, severe infection, etc.;
- Severe psychiatric disease or potential suicide risk;
- Within 3 years after radical surgery for malignant tumor;
- Participation in other interventional clinical trials within the past three months;
- In the physician's judgment, poor compliance, inability to complete, or unwillingness to cooperate with regular postoperative follow-up;
- Other circumstances that the physician considers unsuitable for this clinical trial.
- Anti-Aβ monoclonal antibody treatment has been received within half a year
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil group
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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.
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アクティブコンパレータ:Oral donepezil group
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 12
時間枠:Baseline and Month 12
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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.
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Baseline and Month 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Mini-Mental State Examination Score at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Montreal Cognitive Assessment Score at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in 18-item Apathy Evaluation Scale Score at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Neuropsychiatric Inventory Total Score at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Basic Activities of Daily Living Score at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Instrumental Activities of Daily Living Score at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in PET Imaging Measures at Month 18
時間枠:Baseline and Month 18
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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
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Change From Baseline in Brain Volumetric MRI Measures at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Glymphatic System-Related MRI Measures at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Internal Jugular Vein Diameter on Ultrasound at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in External Jugular Vein Diameter on Ultrasound at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Maximum Jugular Vein Flow Velocity on Ultrasound at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Histopathological Findings in Intraoperatively Collected Lymph Node Tissue
時間枠:During surgery
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Histopathological findings in lymph node tissue collected intraoperatively, when available, will be assessed using routine histopathological staining.
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During surgery
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Concentration of Phosphorylated Tau 217 in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of phosphorylated tau 217 (P-tau217) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Amyloid-Beta 42 in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of amyloid-beta 42 (Aβ42) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Phosphorylated Tau 181 in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of phosphorylated tau 181 (P-tau181) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/ml).
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During surgery
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Concentration of Amyloid-Beta 40 in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of amyloid-beta 40 (Aβ40) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Neurofilament Light Chain in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of neurofilament light chain (NfL) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Glial Fibrillary Acidic Protein in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of glial fibrillary acidic protein (GFAP) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Interleukin-1 Alpha in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of interleukin-1 alpha (IL-1α) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Interleukin-1 Beta in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of interleukin-1 beta (IL-1β) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Interleukin-8 in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of interleukin-8 (IL-8) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Tumor Necrosis Factor Alpha in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of tumor necrosis factor alpha (TNF-α) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Interleukin-12 in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of interleukin-12 (IL-12) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Interleukin-6 in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of interleukin-6 (IL-6) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Interferon Gamma in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of interferon gamma (IFN-γ) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Interleukin-17A in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of interleukin-17A (IL-17A) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Interleukin-4 in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of interleukin-4 (IL-4) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Interleukin-10 in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of interleukin-10 (IL-10) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Interleukin-1 Receptor Antagonist in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of interleukin-1 receptor antagonist (IL-1ra) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Concentration of Transforming Growth Factor Beta in Intraoperatively Collected Lymphatic Fluid
時間枠:During surgery
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The concentration of transforming growth factor beta (TGF-β) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).
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During surgery
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Change From Baseline in Cerebrospinal Fluid P-tau181 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid Total Tau Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid Aβ42 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid Aβ40 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid Aβ42/Aβ40 Ratio at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid BD-tau Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid GFAP Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid NfL Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid pTau217 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid IL-1α Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid IL-1β Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid IL-8 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid TNF-α Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid IL-12 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid IL-6 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid IFN-γ Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid IL-17A Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid IL-4 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid IL-10 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid IL-1ra Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Cerebrospinal Fluid TGF-β Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Plasma P-tau181 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Plasma Total Tau Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Plasma Aβ42 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Plasma Aβ40 Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Plasma Aβ42/Aβ40 Ratio at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Plasma BD-tau Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Plasma GFAP Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Plasma NfL Level at Month 18
時間枠:Baseline and Month 18
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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.
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Baseline and Month 18
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Change From Baseline in Plasma pTau217 Level at Month 18
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Sims JR, Zimmer JA, Evans CD, Lu M, Ardayfio P, Sparks J, Wessels AM, Shcherbinin S, Wang H, Monkul Nery ES, Collins EC, Solomon P, Salloway S, Apostolova LG, Hansson O, Ritchie C, Brooks DA, Mintun M, Skovronsky DM; TRAILBLAZER-ALZ 2 Investigators. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023 Aug 8;330(6):512-527. doi: 10.1001/jama.2023.13239.
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- Zhang XX, Tian Y, Wang ZT, Ma YH, Tan L, Yu JT. The Epidemiology of Alzheimer's Disease Modifiable Risk Factors and Prevention. J Prev Alzheimers Dis. 2021;8(3):313-321. doi: 10.14283/jpad.2021.15.
- Jack CR Jr, Andrews JS, Beach TG, Buracchio T, Dunn B, Graf A, Hansson O, Ho C, Jagust W, McDade E, Molinuevo JL, Okonkwo OC, Pani L, Rafii MS, Scheltens P, Siemers E, Snyder HM, Sperling R, Teunissen CE, Carrillo MC. Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimers Dement. 2024 Aug;20(8):5143-5169. doi: 10.1002/alz.13859. Epub 2024 Jun 27.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月15日
一次修了 (推定)
2028年9月30日
研究の完了 (推定)
2029年3月31日
試験登録日
最初に提出
2026年6月7日
QC基準を満たした最初の提出物
2026年6月25日
最初の投稿 (実際)
2026年7月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月2日
QC基準を満たした最後の更新が送信されました
2026年6月25日
最終確認日
2026年3月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SH9H-2025-T549
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
アルツハイマー病の臨床試験
-
Peking University Third Hospital招待による登録
-
University of California, Los Angeles募集アルツハイマー病 | 認知症アルツハイマー型 | Alzheimer&amp;#39; s病(AD) | アルツハイマー&Amp;Amp;#39;病 | 軽度アルツハイマー&Amp;Amp;#39;s病 | 中等度アルツハイマー&Amp;Amp;#39;s病 | アルツハイマー型認知症アメリカ
-
Baylor College of Medicine募集
-
Royal Marsden NHS Foundation TrustPelican Cancer Foundation完了
-
Cairo UniversitySamuel Bekhet Moawad; Ahmed Shaker Ragab; Michael Wahib Wadid完了U/S Guided SAB VS U/S Guided SAB と修正胸神経ブロックの併用エジプト
-
Standard Process Inc.Nutrasource Pharmaceutical and Nutraceutical Services, Inc.完了
-
Meng QiuBeijing Xisike Clinical Oncology Research Foundation募集
-
Yeungnam University HospitalChonbuk National University Hospital; Samsung Medical Center; Chonnam National University Hospital と他の協力者まだ募集していません
-
City of Hope Medical CenterNational Cancer Institute (NCI); Hope Foundation完了癌を克服した人 | I期直腸S状がん | II期の直腸S状がん | III期の直腸S状がんアメリカ