Alzheimer's Disease (AD)Phase 1Neck LVANCT07458620
Prospective Single-Arm Safety Study of Cervical LVA in AD Patients
A Phase 1 study testing Supermicrosurgical Lymphaticovenular Anastomosis (LVA) in people with Alzheimer's Disease (AD), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Official Title Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients with Alzheimer's Disease Purpose of the Study Researchers are conducting this study to see if a minimally invasive microsurgery, called Cervical Lymphaticovenular Anastomosis (LVA), is safe for people with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- Supermicrosurgical Lymphaticovenular Anastomosis (LVA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2026to Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Alzheimer's Disease: Participants must have a confirmed diagnosis of Alzheimer's Disease as evaluated by a neurologist and a psychiatrist at the hospital.
- Positive Amyloid-PET Scan: The result of a [18F] Florbetapir (Amyloid-PET) scan must be positive, indicating the presence of amyloid plaques in the brain.
- Willingness to Consent: Participants or their legal representatives must be willing to sign a written informed consent form.
- Participants must be adults aged 18 years or older
Who cannot join
- Lack of Informed Consent: Potential participants are excluded if they are unable to exercise autonomy and informed consent cannot be obtained from a legal representative or authorized person.
- Prior Surgical History: Individuals who have previously undergone neck lymphatic dissection, nasopharyngeal surgery, or intracranial surgery are excluded.
- Concurrent Medical Conditions: The trial excludes persons with thyroid disease or chronic heart failure.
- Specific Allergies: Candidates with a history of allergies to shellfish or iodine are excluded due to the use of Indocyanine Green (ICG) during the procedure.
- Unresolved Concerns: Anyone who has doubts about the trial and cannot receive satisfactory answers is excluded.
- Anesthesia Risks: Individuals deemed medically unfit for general anesthesia-for example, those with severe cardiopulmonary insufficiency or a history of specific anesthetic drug allergies-are ineligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Johnson Chia-Shen Yang, MD, PhD, +886-975056253, johnson.c.yang@gmail.com
About this study
Official title: Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients With Alzheimer's Disease
Official Title Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients with Alzheimer's Disease
Purpose of the Study Researchers are conducting this study to see if a minimally invasive microsurgery, called Cervical Lymphaticovenular Anastomosis (LVA), is safe for people with Alzheimer's Disease.
Read more
How the Surgery Works Alzheimer's Disease is linked to the buildup of metabolic waste products (certain proteins) in the brain. Recent medical discoveries show that these wastes normally drain through small channels in the neck into the blood system. In this study, surgeons will use high-powered microscopes to connect these drainage channels (lymphatic vessels) in the neck directly to small nearby veins. The goal is to create a "detour" that helps the brain clear out these harmful proteins more effectively.
What to Expect Safety First: The main goal is to find out if the surgery is safe and well-tolerated by patients.
The Procedure: The surgery is performed under general anesthesia and typically takes 4 to 6 hours. It involves small (about 5 cm) incisions on both sides of the neck.
Follow-up: Participants will be monitored for at least 12 months. Researchers will use memory tests, brain scans (MRI and PET), and blood tests to see if the surgery helps with daily activities or slows down memory loss.
Read the detailed description
Official Title Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients with Alzheimer's Disease
Scientific Rationale Neurodegenerative diseases like Alzheimer's (AD) are characterized by the misfolding and accumulation of proteins such as Amyloid-beta and Tau. The glymphatic and meningeal lymphatic systems serve as the primary pathways for clearing these metabolic wastes from the central nervous system into the deep cervical lymph nodes. This study investigates whether enhancing this drainage via supermicrosurgical lymphaticovenular anastomosis (LVA) can reduce intracranial protein burden and systemic oxidative stress.
Study Design and Intervention This is a prospective, single-arm safety study. Participants undergo bilateral cervical LVA. Using Indocyanine Green (ICG) fluorescence lymphography for navigation, lymphatic vessels in the neck are identified and anastomosed to adjacent small veins to facilitate lymph drainage into the venous circulation.
Safety Monitoring and Data Integrity Primary Safety Endpoint: The study defines safety as a Serious Adverse Event (SAE) rate of ≤10% within the first month post-operation. Events are graded using CTCAE v5.0.
Independent Oversight: To ensure objectivity, cognitive and behavioral assessments (including MMSE, CDR, and CASI) are conducted by clinical psychologists who are not members of the core research team.
External Auditing: An independent Clinical Research Organization (CRO) has been contracted to perform four periodic audits to verify data accuracy and GCP compliance.
Exploratory Objectives
The study will track longitudinal changes in:
Fluid Biomarkers: Plasma levels of Amyloid-beta 40/42, p-Tau 217, GFAP, and Nf-L at baseline, 1, 6, and 12 months.
Neuroimaging: Amyloid-PET and FDG-PET scans at baseline and 12 months to evaluate protein deposition and metabolic activity.
Clinical Outcomes: Changes in cognitive scores (CDR, MMSE, CASI, NPI) from baseline to 6 months post-surgery.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- Supermicrosurgical Lymphaticovenular Anastomosis (LVA)
- Keywords
- Alzheimer's Disease (AD), Neurodegenerative Diseases, Dementia, Lymphaticovenular Anastomosis (LVA), Supermicrosurgery, Cervical Lymphatic Bypass, Glymphatic System Clearance, Meningeal Lymphatic System, Amyloid-beta (Aβ) Drainage, Tau Protein Clearance, CSF, Deep Cervical Lymph Nodes (dCLNs), Amyloid-PET Imaging, Indocyanine Green (ICG) Lymphography
- Medical subject headings
- Alzheimer Disease, Neurodegenerative Diseases, Dementia, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supermicrosurgical Lymphaticovenular Anastomosis (LVA)Procedure or surgery
This intervention is uniquely distinguished by its use of supermicrosurgery to perform bilateral cervical Lymphaticovenular Anastomosis (LVA) as a direct physiological treatment for Alzheimer's Disease. Unlike traditional pharmacological trials that target protein production or aggregation, this surgical approach focuses on the mechanical clearance of metabolic waste.
A key technical differentiator is the specific targeting of neck lymph nodes using Indocyanine Green (ICG) fluorescence to map the drainage pathway of cerebrospinal fluid. This allows for a precise, "super-microsurgical" bypass (connecting vessels often <0.8mm) in the neck. This method aims to bypass potential blockages in the aging dCLNs (deep cervical lymph nodes), directly enhancing the outflow of Amyloid-beta and Taufrom the glymphatic and meningeal systems into the venous circulation.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Cervical LVA Intervention Supporting Context Arm Type | Experimental | The single experimental arm involves bilateral cervical supermicrosurgical Lymphaticovenular Anastomosis (LVA). Participants undergo a surgical procedure where high-power microscopy is used to identify cervical lymphatic vessels. These vessels are then microsurgically connected (anastomosed) to adjacent small veins to create an extra-cranial bypass.
The intervention utilizes Indocyanine Green (ICG) fluorescence imaging to precisely map the lymphatic drainage pathways in the neck. The primary goal of this bypass is to enhance the clearance of metabolic waste-specifically Amyloid-beta and tau proteins-from the brain by facilitating their drainage from the glymphatic and meningeal lymphatic systems into the systemic venous circulation. This trial evaluates the safety and feasibility of this approach in mitigating the progression of Alzheimer's Disease. Receives: Procedure: Supermicrosurgical Lymphaticovenular Anastomosis (LVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Feasibility)
Assessment of the safety and feasibility of bilateral cervical supermicrosurgical lymphaticovenular anastomosis (LVA). Safety is evaluated by the frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring from the start of the surgical procedure through the 1-month post-operative follow-up period. Events are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From the start of surgery up to 1 month post-operation.
Secondary outcomes (5)
Change from Baseline in Mini-Mental State Examination (MMSE) Score
A 30-point questionnaire used to measure cognitive impairment. Lower scores indicate greater impairment.
Measured: Baseline and 6 months post-operation
Change from Baseline in Clinical Dementia Rating (CDR)
A scale used to characterize the level of cognitive and functional performance.
Measured: Baseline and 6 months post-operation.
Changes from Baseline in Cognitive Abilities Screening Instrument (CASI)
The CASI is a comprehensive tool used to assess multiple cognitive domains, including attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, and abstraction. It provides a more detailed assessment than the MMSE, with a total score ranging from 0 to 100. Higher scores indicate better cognitive performance, while lower scores represent greater impairment.
Measured: Baseline and 6 months post-operation.
Change in Brain Amyloid-beta Deposition via PET Scan
Assessment of the change in brain amyloid plaque density using [18F] Florbetapir (Amyloid-PET) imaging. This measures whether the surgical intervention has facilitated the clearance of pathological proteins.
Measured: Baseline and post-operation.
Change in Plasma Neurodegenerative Biomarker Levels
Quantification of plasma levels for GFAP and NfL. These markers are used to track neuroaxonal damage and protein clearance efficiency.
Measured: Baseline and post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458620
- Sponsor's protocol ID
- 202500102A0
- Acronym
- Neck LVA
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. Data Protection and Retention Limits: The protocol strictly mandates that all de-identified data and specimens will be destroyed five years after the formal conclusion of the trial. 2. Privacy and Confidentiality: To protect the privacy of participants, data is stored under locked and encrypted conditions, with access restricted to the immediate research team members. 3. Restricted Future Use: While participants can consent to have their data stored in the hospital's internal biobank, this authorization is limited specifically to future research within Kaohsiung Chang Gung Memorial Hospital and does not extend to public or external sharing. 4. Legal Representative Consent: Because the study involves participants with cognitive impairments who may lack the capacity to exercise autonomy, data management is subject to strict ethical oversight that prioritizes the protection of the participants' rights over broad data dissemination.
Publications
Louveau A, Smirnov I, Keyes TJ, Eccles JD, Rouhani SJ, Peske JD, Derecki NC, Castle D, Mandell JW, Lee KS, Harris TH, Kipnis J. Structural and functional features of central nervous system lymphatic vessels. Nature. 2015 Jul 16;523(7560):337-41. doi: 10.1038/nature14432. Epub 2015 Jun 1.
PubMed 26030524Hong JP, Chen WF, Nguyen DH, Xie Q. A Proposed Role for Lymphatic Supermicrosurgery in the Management of Alzheimer's Disease: A Primer for Reconstructive Microsurgeons. Arch Plast Surg. 2025 Jan 30;52(2):96-103. doi: 10.1055/a-2513-4313. eCollection 2025 Mar.
PubMed 40083619
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07458620
- Acronym / sponsor ID
- Neck LVA / 202500102A0
- Conditions
- Alzheimer's Disease (AD)
- Keywords
- Alzheimer's Disease (AD), Neurodegenerative Diseases, Dementia, Lymphaticovenular Anastomosis (LVA), Supermicrosurgery, Cervical Lymphatic Bypass, Glymphatic System Clearance, Meningeal Lymphatic System
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Official Title Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients with Alzheimer's Disease
Purpose of the Study Researchers are conducting this study to see if a minimally invasive microsurgery, called Cervical Lymphaticovenular Anastomosis (LVA), is safe for people with Alzheimer's Disease.
How the Surgery Works Alzheimer's Disease is linked to the buildup of metabolic waste products (certain proteins) in the brain. Recent medical discoveries show that these wastes normally drain through small channels in the neck into the blood system. In this study, surgeons will use high-powered microscopes to connect these drainage channels (lymphatic vessels) in the neck directly to small nearby veins. The goal is to create a "detour" that helps the brain clear out these harmful proteins more effectively.
What to Expect Safety First: The main goal is to find out if the surgery is safe and well-tolerated by patients.
The Procedure: The surgery is performed under general anesthesia and typically takes 4 to 6 hours. It involves small (about 5 cm) incisions on both sides of the neck.
Follow-up: Participants will be monitored for at least 12 months. Researchers will use memory tests, brain scans (MRI and PET), and blood tests to see if the surgery helps with daily activities or slows down memory loss.
Detailed description
Official Title Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients with Alzheimer's Disease
Scientific Rationale Neurodegenerative diseases like Alzheimer's (AD) are characterized by the misfolding and accumulation of proteins such as Amyloid-beta and Tau. The glymphatic and meningeal lymphatic systems serve as the primary pathways for clearing these metabolic wastes from the central nervous system into the deep cervical lymph nodes. This study investigates whether enhancing this drainage via supermicrosurgical lymphaticovenular anastomosis (LVA) can reduce intracranial protein burden and systemic oxidative stress.
Study Design and Intervention This is a prospective, single-arm safety study. Participants undergo bilateral cervical LVA. Using Indocyanine Green (ICG) fluorescence lymphography for navigation, lymphatic vessels in the neck are identified and anastomosed to adjacent small veins to facilitate lymph drainage into the venous circulation.
Safety Monitoring and Data Integrity Primary Safety Endpoint: The study defines safety as a Serious Adverse Event (SAE) rate of ≤10% within the first month post-operation. Events are graded using CTCAE v5.0.
Independent Oversight: To ensure objectivity, cognitive and behavioral assessments (including MMSE, CDR, and CASI) are conducted by clinical psychologists who are not members of the core research team.
External Auditing: An independent Clinical Research Organization (CRO) has been contracted to perform four periodic audits to verify data accuracy and GCP compliance.
Exploratory Objectives
The study will track longitudinal changes in:
Fluid Biomarkers: Plasma levels of Amyloid-beta 40/42, p-Tau 217, GFAP, and Nf-L at baseline, 1, 6, and 12 months.
Neuroimaging: Amyloid-PET and FDG-PET scans at baseline and 12 months to evaluate protein deposition and metabolic activity.
Clinical Outcomes: Changes in cognitive scores (CDR, MMSE, CASI, NPI) from baseline to 6 months post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Cervical LVA Intervention Supporting Context Arm Type | Experimental | Procedure: Supermicrosurgical Lymphaticovenular Anastomosis (LVA)The single experimental arm involves bilateral cervical supermicrosurgical Lymphaticovenular Anastomosis (LVA). Participants undergo a surgical procedure where high-power microscopy is used to identify cervical lymphatic vessels. These vessels are then microsurgically connected (anastomosed) to adjacent small veins to create an extra-cranial bypass. The intervention utilizes Indocyanine Green (ICG) fluorescence imaging to precisely map the lymphatic drainage pathways in the neck. The primary goal of this bypass is to enhance the clearance of metabolic waste-specifically Amyloid-beta and tau proteins-from the brain by facilitating their drainage from the glymphatic and meningeal lymphatic systems into the systemic venous circulation. This trial evaluates the safety and feasibility of this approach in mitigating the progression of Alzheimer's Disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Alzheimer's Disease: Participants must have a confirmed diagnosis of Alzheimer's Disease as evaluated by a neurologist and a psychiatrist at the hospital.
- Positive Amyloid-PET Scan: The result of a [18F] Florbetapir (Amyloid-PET) scan must be positive, indicating the presence of amyloid plaques in the brain.
- Willingness to Consent: Participants or their legal representatives must be willing to sign a written informed consent form.
- Participants must be adults aged 18 years or older
Key exclusion criteria (6 listed)
- Lack of Informed Consent: Potential participants are excluded if they are unable to exercise autonomy and informed consent cannot be obtained from a legal representative or authorized person.
- Prior Surgical History: Individuals who have previously undergone neck lymphatic dissection, nasopharyngeal surgery, or intracranial surgery are excluded.
- Concurrent Medical Conditions: The trial excludes persons with thyroid disease or chronic heart failure.
- Specific Allergies: Candidates with a history of allergies to shellfish or iodine are excluded due to the use of Indocyanine Green (ICG) during the procedure.
- Unresolved Concerns: Anyone who has doubts about the trial and cannot receive satisfactory answers is excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supermicrosurgical Lymphaticovenular Anastomosis (LVA)This intervention is uniquely distinguished by its use of supermicrosurgery to perform bilateral cervical Lymphaticovenular Anastomosis (LVA) as a direct physiological treatment for Alzheimer's Disease. Unlike traditional pharmacological trials that target protein production or aggregation, this surgical approach focuses on the mechanical clearance of metabolic waste. A key technical differentiator is the specific targeting of neck lymph nodes using Indocyanine Green (ICG) fluorescence to map the drainage pathway of cerebrospinal fluid. This allows for a precise, "super-microsurgical" bypass (connecting vessels often <0.8mm) in the neck. This method aims to bypass potential blockages in the aging dCLNs (deep cervical lymph nodes), directly enhancing the outflow of Amyloid-beta and Taufrom the glymphatic and meningeal systems into the venous circulation. | Procedure or surgery | Single-Arm Cervical LVA Intervention Supporting Context Arm Type |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Feasibility)
Time frame: From the start of surgery up to 1 month post-operation.
Assessment of the safety and feasibility of bilateral cervical supermicrosurgical lymphaticovenular anastomosis (LVA). Safety is evaluated by the frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring from the start of the surgical procedure through the 1-month post-operative follow-up period. Events are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
5 secondary outcomes
Change from Baseline in Mini-Mental State Examination (MMSE) Score
Time frame: Baseline and 6 months post-operation
Change from Baseline in Clinical Dementia Rating (CDR)
Time frame: Baseline and 6 months post-operation.
Changes from Baseline in Cognitive Abilities Screening Instrument (CASI)
Time frame: Baseline and 6 months post-operation.
Change in Brain Amyloid-beta Deposition via PET Scan
Time frame: Baseline and post-operation.
Change in Plasma Neurodegenerative Biomarker Levels
Time frame: Baseline and post-operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 26030524Louveau A, Smirnov I, Keyes TJ, Eccles JD, Rouhani SJ, Peske JD, Derecki NC, Castle D, Mandell JW, Lee KS, Harris TH, Kipnis J. Structural and functional features of central nervous system lymphatic vessels. Nature. 2015 Jul 16;523(7560):337-41. doi: 10.1038/nature14432. Epub 2015 Jun 1.
- Background: PubMed 40083619Hong JP, Chen WF, Nguyen DH, Xie Q. A Proposed Role for Lymphatic Supermicrosurgery in the Management of Alzheimer's Disease: A Primer for Reconstructive Microsurgeons. Arch Plast Surg. 2025 Jan 30;52(2):96-103. doi: 10.1055/a-2513-4313. eCollection 2025 Mar.
- Individual participant dataSharing planned: No. 1. Data Protection and Retention Limits: The protocol strictly mandates that all de-identified data and specimens will be destroyed five years after the formal conclusion of the trial. 2. Privacy and Confidentiality: To protect the privacy of participants, data is stored under locked and encrypted conditions, with access restricted to the immediate research team members. 3. Restricted Future Use: While participants can consent to have their data stored in the hospital's internal biobank, this authorization is limited specifically to future research within Kaohsiung Chang Gung Memorial Hospital and does not extend to public or external sharing. 4. Legal Representative Consent: Because the study involves participants with cognitive impairments who may lack the capacity to exercise autonomy, data management is subject to strict ethical oversight that prioritizes the protection of the participants' rights over broad data dissemination.
Related trials for Alzheimer's Disease (AD)
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Supermicrosurgical Lymphaticovenular Anastomosis (LVA) in people with Alzheimer's Disease (AD), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johnson Chia-Shen Yang,, MD, PhD (+886-975056253, johnson.c.yang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and Feasibility) (time frame: From the start of surgery up to 1 month post-operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07458620, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.