Cervical Lymphatic Microsurgery in Alzheimer's Disease
Microsurgical Modification of Cervical Lymphatic Pathways in Alzheimer's Disease: A Pilot Study
This pilot study will evaluate whether microsurgical modification of cervical lymphatic drainage may influence blood biomarkers and clinical outcomes in people with mild Alzheimer's disease.
Thirty participants will be randomly assigned in a 1:1 ratio to either a surgical intervention group or a control group. Participants in the intervention group will undergo supermicrosurgical lymphaticovenous anastomosis (LVA) and/or lymph node-to-vein anastomosis (LNVA) in the neck to create an alternative pathway for lymphatic drainage. The procedure may be performed manually or with robotic microsurgical assistance. Participants in the control group will receive clinical observation without surgery during the first 12 months.
The primary objective is to assess the change in plasma phosphorylated tau 217 (p-tau217) from baseline to 12 months. The study will also assess changes in cognitive and functional measures, including the Clinical Dementia Rating Sum of Boxes (CDR-SB), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Montreal Cognitive Assessment (MoCA), and Mini-Mental State Examination (MMSE), as well as the feasibility and safety of the surgical procedure.
Participants will be assessed at baseline and at 3, 6, and 12 months. After completion of the 12-month observation period, participants in the control group may be offered the surgical procedure if they wish to undergo it.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Daniel Maliszewski, MD, PhD
- 電話番号：+48 501784896
- メール：danielmal2@gmail.com
研究連絡先のバックアップ
- 名前：Kamil Chwojnicki, MD, PhD
- 電話番号：+48 506135515
- メール：kchwoj@gumed.edu.pl
研究場所
-
-
-
Gdansk、ポーランド、80-952
- 募集
- Uniwersyteckie Centrum Kliniczne w Gdańsku
-
コンタクト：
- Kamil Chwojnicki, MD, PhD
- 電話番号：+48 506 135 515
- メール：kchwoj@gumed.edu.pl
-
主任研究者：
- Kamil Chwojnicki, MD, PhD
-
Słupsk、ポーランド、76-200
- 募集
- Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
-
コンタクト：
- Daniel Maliszewski, MD, PhD
- 電話番号：+48 501 784 896
- メール：danielmal2@gmail.com
-
主任研究者：
- Daniel Maliszewski, MD, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18 years or older
- Clinical diagnosis of mild Alzheimer's disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
- Clinical Dementia Rating (CDR) score of 0.5 to 1.0.
- Mini-Mental State Examination (MMSE) score of 20 to 26.
- Confirmation of Alzheimer's disease pathology using plasma biomarkers, with elevated phosphorylated tau 217 (p-tau217).
- Stable pharmacological treatment for Alzheimer's disease for at least 3 months before enrollment.
- Ability to provide informed consent or consent provided by a legally authorized representative.
Exclusion Criteria:
- Moderate or severe Alzheimer's disease.
- Other neurodegenerative disorders or significant psychiatric disorders.
- Previous major neck surgery or radiotherapy to the neck that may affect lymphatic drainage.
- Contraindications to general anesthesia.
- Active infection or coagulation disorders.
研究計画
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：基礎科学
- 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 |
|---|---|
|
実験的：Surgical Intervention
Participants assigned to this arm will undergo supermicrosurgical modification of cervical lymphatic drainage using lymphaticovenous anastomosis (LVA) and/or lymph node-to-vein anastomosis (LNVA). The procedure may be performed manually or with robotic microsurgical assistance. |
Supermicrosurgical modification of cervical lymphatic drainage by creation of lymphaticovenous anastomosis (LVA) and/or lymph node-to-vein anastomosis (LNVA). Preoperative lymphatic and venous mapping is performed using ultra-high-frequency ultrasound and indocyanine green fluorescence imaging. The procedure is performed under general anesthesia and may be carried out manually or with robotic supermicrosurgical assistance. The specific anastomotic technique and configuration are selected according to the identified lymphatic and venous anatomy.
他の名前：
|
|
介入なし：Control
Participants assigned to this arm will undergo clinical observation without surgical intervention during the first 12 months. After completion of the 12-month observation period, participants may elect to undergo the surgical procedure. |
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 |
|---|---|---|
|
Change in Plasma Phosphorylated Tau 217 (p-tau217) Concentration From Baseline to Month 12
時間枠：Baseline to Month 12
|
Change in plasma phosphorylated tau 217 (p-tau217) concentration from baseline to the 12-month follow-up. The change over time will be compared between the surgical intervention and control groups. |
Baseline to Month 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in CDR-SB Score From Baseline to Month 12
時間枠：Baseline to Month 12
|
The Clinical Dementia Rating Sum of Boxes (CDR-SB) score ranges from 0 to 18, with higher scores indicating greater cognitive and functional impairment and therefore a worse clinical outcome. Change in CDR-SB score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates worsening, whereas a negative change indicates improvement. |
Baseline to Month 12
|
|
Change in ADCS-ADL Score From Baseline to Month 12
時間枠：Baseline to Month 12
|
The 23-item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) total score ranges from 0 to 78, with higher scores indicating better performance in activities of daily living and therefore a better functional outcome. Change in ADCS-ADL total score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates improvement, whereas a negative change indicates worsening. |
Baseline to Month 12
|
|
Change in MoCA Score From Baseline to Month 12
時間枠：Baseline to Month 12
|
The Montreal Cognitive Assessment (MoCA) total score ranges from 0 to 30, with higher scores indicating better cognitive performance and therefore a better cognitive outcome. Change in MoCA total score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates improvement, whereas a negative change indicates worsening. |
Baseline to Month 12
|
|
Change in MMSE Score From Baseline to Month 12
時間枠：Baseline to Month 12
|
The Mini-Mental State Examination (MMSE) total score ranges from 0 to 30, with higher scores indicating better cognitive performance and therefore a better cognitive outcome. Change in MMSE total score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates improvement, whereas a negative change indicates worsening. |
Baseline to Month 12
|
|
Procedure-Related Adverse Events and Serious Adverse Events
時間枠：From surgery through Month 12
|
Occurrence of adverse events and serious adverse events related to the surgical procedure during the study follow-up period. |
From surgery through Month 12
|
|
Postoperative Complications
時間枠：From surgery through Month 12
|
Occurrence of postoperative complications following cervical lymphatic microsurgery, including local surgical complications assessed during follow-up. |
From surgery through Month 12
|
|
Rehospitalization
時間枠：Up to Month 12
|
Occurrence of rehospitalization during the 12-month study follow-up period. |
Up to Month 12
|
|
All-Cause Mortality
時間枠：Up to Month 12
|
Occurrence of death from any cause during the 12-month study follow-up period. |
Up to Month 12
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- AD-LVA-LNVA-2026-01
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?
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
米国FDA規制機器製品の研究
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。