Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease (DCLVA-AD)
2026年6月21日 更新者：Rong Hu, MD、Southwest Hospital, China
A Single-arm, Prospective, Self-controlled Study on Efficacy and Safety of Deep Cervical Lymphovenous Anastomosis for Neurological Function in Patients With Severe Alzheimer's Disease
Alzheimer's disease (AD) is a severe neurodegenerative disease with heavy social burden.
Current drugs cannot reverse disease progression.
Brain glymphatic system and meningeal lymphatic dysfunction lead to impaired clearance of Aβ and Tau protein, which is an important pathogenesis of AD.
Deep cervical lymphovenous anastomosis (DCLVA) can improve intracranial lymphatic drainage, promote the clearance of toxic proteins, and improve neurological function.
This is a single-arm, prospective, self-controlled study to enroll 59 patients with severe AD (MMSE < 10).
All patients receive bilateral DCLVA plus routine medication.
The primary endpoint is change of CDR-SB score at 12 months post-operation.
Secondary endpoints include MMSE, ZBI scores and Aβ PET-CT Centiloid value.
This study aims to verify the efficacy and safety of DCLVA for severe AD.
調査の概要
研究の種類
介入
入学 (推定)
59
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：Rong Hu, MD
- 電話番号：+8602368765911
- メール：huchrong@tmmu.edu.cn
研究連絡先のバックアップ
- 名前：Jingyu Chen, MD
- 電話番号：+8602368765911
- メール：283686484@qq.com
研究場所
-
-
Chongqing Municipality
-
Chongqing、Chongqing Municipality、中国、400038
- The First Affiliated Hospital of Army Medical University (Southwest Hospital)
-
コンタクト：
- Jingyu Chen, MD
- 電話番号：+8602368765911
- メール：283686484@qq.com
-
-
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:
- Meet the 2011 NIA-AA clinical diagnostic criteria for probable Alzheimer's disease dementia and the 2018 NIA-AA research framework biomarker criteria for AD.
- Aged 50 to 80 years (inclusive) at the time of signing informed consent.
- Severe cognitive dysfunction: Mini-Mental State Examination (MMSE) score < 10 points.
- Progressive cognitive deterioration for more than 6 months reported by patient or caregiver.
- No clinical improvement after more than 6 months of standardized drug treatment.
- Have a designated study companion who signs informed consent, contacts the patient at least 10 hours per week and accompanies study visits.
- Able to complete scale assessments and examinations independently or with companion assistance.
- Voluntarily comply with study procedures, examinations and surgical treatment.
- Patient or legal representative can sign written informed consent and abide by trial requirements.
- Patients and families are informed of study purpose, expected efficacy and potential risks, and voluntarily provide biological samples and participate in the study.
Exclusion Criteria:
- Severe central nervous system diseases (other than AD) that affect cognitive function or study compliance.
- Severe/unstable systemic diseases (cardiovascular, hepatic, renal, respiratory, endocrine, hematological, psychiatric diseases); life expectancy less than 24 months.
- Surgical contraindications: severe coagulation disorders, severe -cardiopulmonary diseases (myocardial infarction/respiratory failure within recent 30 days); severe liver damage (ALT/AST > 3 times upper limit of normal); severe renal insufficiency (eGFR < 30ml/min).
- Severe primary mental disorders (other than AD) that interfere with efficacy evaluation and cognitive assessment.
- History of intracranial hemorrhage or craniocerebral trauma within recent 1 year.
- Alcohol or drug abuse/dependence within recent 1 year.
- Allergy to indocyanine green, gadolinium contrast agent, 18F-florbetapir or 18F-flortaucipir.
- Contraindications for PET examination.
- Other conditions judged by investigators unsuitable for enrollment.
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Deep Cervical Lymphovenous Anastomosis plus Routine Treatment
All participants receive one-time bilateral deep cervical lymphovenous anastomosis under microsurgery with indocyanine green lymphatic tracing.
Conventional anti-Alzheimer's drugs are maintained throughout the study.
All outcomes are compared with pre-operation baseline.
|
A one-time microsurgical procedure performed under general anesthesia.
Indocyanine green (ICG) is injected for intraoperative lymphatic vessel tracing under a fluorescent surgical microscope.
Lymphatic vessels or lymphatic flaps are anastomosed to cervical veins via end-to-side or end-to-end technique to improve intracranial lymphatic drainage.
No additional surgical interventions are applied.
Stable administration of standard drugs for Alzheimer's disease, including cholinesterase inhibitors and/or NMDA receptor antagonists, following clinical guidelines.
Participants continue their original medication regimen throughout the whole study period without dose adjustment or drug switching.
|
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 |
|---|---|---|
|
Sum of Boxes (CDR-SB) Total Score
時間枠：Baseline (pre-operation), 12 months after surgery
|
The CDR-SB total score ranges from 0 to 18 points.
Higher scores indicate more severe cognitive impairment and functional decline.
This outcome evaluates the change of total CDR-SB score in patients with severe Alzheimer's disease after receiving deep cervical lymphovenous anastomosis, to assess the therapeutic effect on neurological function.
|
Baseline (pre-operation), 12 months after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sum of Boxes (CDR-SB) Total Score
時間枠：Baseline (pre-operation), 1 month and 6 months after surgery
|
The CDR-SB total score ranges from 0 to 18 points.
Higher scores indicate more severe cognitive impairment and functional decline.
This outcome evaluates the change of total CDR-SB score in patients with severe Alzheimer's disease after receiving deep cervical lymphovenous anastomosis, to assess the therapeutic effect on neurological function.
|
Baseline (pre-operation), 1 month and 6 months after surgery
|
|
Mini-Mental State Examination (MMSE) Score
時間枠：Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
|
MMSE total score ranges from 0 to 30.
Higher scores represent better cognitive function.
A score below 10 indicates severe cognitive impairment.
This measure assesses changes in overall cognitive status after surgical intervention.
|
Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
|
|
Zarit Burden Interview (ZBI) Score
時間枠：Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
|
ZBI total score ranges from 0 to 88.
Higher scores mean heavier caregiver burden.
It is used to evaluate the impact of treatment on the psychological and life burden of patients' caregivers.
|
Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
|
|
Amyloid-beta (Aβ) PET-CT Centiloid Value
時間枠：Baseline (pre-operation), 12 months after surgery
|
Centiloid value reflects the level of cerebral amyloid-beta deposition.
Detect and compare the difference of brain Aβ deposition between baseline and 12 months post-operation.
|
Baseline (pre-operation), 12 months after surgery
|
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。
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10月1日
一次修了 (推定)
2028年9月30日
研究の完了 (推定)
2029年9月30日
試験登録日
最初に提出
2026年6月21日
QC基準を満たした最初の提出物
2026年6月21日
最初の投稿 (実際)
2026年6月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月25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21日
最終確認日
2026年6月1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
- KY2026120
- (A)KY2024136 (その他の識別子：Ethics Committee of the First Affiliated Hospital of the Army Medical University)
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?
未定
IPD プランの説明
Individual participant data (IPD) will not be shared externally.
All participant data is stored and managed locally in compliance with Chinese medical data privacy regulations and hospital internal management rules.
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。