Alzheimer DiseasePhase 1NCT07094438
Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Alzheimer's Disease
A Phase 1 study testing Deep Brain Stimulation, DBS, Deep cervical lymphatic-venous anastomosis, LVA and Recognized pharmacological treatments for AD. in people with Alzheimer Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To investigate the safety of deep brain stimulation (DBS) and cervical deep lymphoid-venous anastomosis (LVA) in the treatment of severe Alzheimer's disease (AD); to investigate the effectiveness of DBS and LVA in the treatment of severe AD, i.e., effects of deep brain stimulation on cognitive function, emotion and… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Deep Brain Stimulation, DBS, Deep cervical lymphatic-venous anastomosis, LVA and Recognized pharmacological treatments for AD.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to Jul 2027
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting the diagnostic criteria for dementia formulated by the National Institute on Aging-Alzheimer's Association (NIA-AA).
- Clinical Dementia Rating (CDR) score of 3 points.
- Ability to ambulate independently or with the aid of a walker/cane.
- Adequate visual and auditory capacity to cooperate with examinations and treatment.
- Voluntary participation with written informed consent provided by both the subject and their legal guardian.
Who cannot join
- Pre-existing abnormal brain structure (e.g., tumor, cerebral infarction, hydrocephalus, or intracranial hemorrhage).
- Comorbidity with other neurological disorders such as multiple sclerosis, epilepsy, or Parkinson's disease.
- Psychiatric disorders: e.g., anxiety, depression, other affective disorders, or drug-induced psychosis.
- Severe internal diseases, currently using respiratory/cardiovascular/anticonvulsant/psychotropic drugs, or clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular diseases, cancer, alcoholism, or substance addiction.
- Severe auditory or visual impairment.
- Clinical comorbidities with life expectancy <2 years.
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- History of cranial surgery.
- Contraindications to MRI or transcranial alternating current stimulation (tACS) (e.g., cardiac pacemaker, post-deep brain stimulation surgery).
- Eczema or sensitive skin.
- Familial Alzheimer's disease.
- Other types of dementia: e.g., vascular dementia, Lewy body dementia, frontotemporal dementia, or infectious dementia;
- Any other condition deemed by the investigator as unsuitable for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Zhiqi Mao, Ph.D, 8618910155994, markmaoqi@126.com
Zhiqi Mao, Ph.D
About this study
Official title: Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Patients With Severe Alzheimer's Disease
To investigate the safety of deep brain stimulation (DBS) and cervical deep lymphoid-venous anastomosis (LVA) in the treatment of severe Alzheimer's disease (AD); to investigate the effectiveness of DBS and LVA in the treatment of severe AD, i.e., effects of deep brain stimulation on cognitive function, emotion and life quality in patients with severe AD.
- Conditions
- Alzheimer Disease
- Being tested
- Deep Brain Stimulation, DBS, Deep cervical lymphatic-venous anastomosis, LVA, Recognized pharmacological treatments for AD.
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation, DBSProcedure or surgery
Deep brain stimulation (DBS) is performed after preoperative MRI and CT images are fused in a planning system to determine the target and trajectory. Under general anesthesia, electrodes are precisely implanted into the fornix or nucleus basalis of Meynert using a stereotactic frame or neurosurgical robot. The electrodes are inserted through a burr hole in the patient's skull and connected to a pulse generator placed subcutaneously in the chest. Optimal stimulation parameters for Alzheimer's disease are not yet established. For fornix targets, settings are typically 3-3.5 V, ~130 Hz, 90 μs; for nucleus basalis targets, 2-4.5 V, 10-20 Hz, 90-150 μs, adjusted according to anatomical features and intraoperative responses.
Deep cervical lymphatic-venous anastomosis, LVAProcedure or surgery
Cervical deep lymphaticovenous anastomosis (LVA) microsurgically connects deep cervical lymphatic vessels to adjacent veins, promoting drainage of brain-derived amyloid-β and tau into the venous system and potentially alleviating Alzheimer's disease symptoms. The minimally invasive neck procedure involves small incisions and high-magnification suturing of lymphatics and veins with ultra-fine (11-0 or 12-0) sutures, creating multiple anastomoses to enhance brain lymphatic outflow.
Recognized pharmacological treatments for AD.Drug
Patients in the medication group received only the currently recognized pharmacological treatments for AD, including Memantine Hydrochloride and Donepezil.
| Study group | Role | What they receive |
|---|---|---|
| DBS arm | Experimental | Patients in the DBS group underwent deep brain electrode implantation, followed by cranial MRI and CT to verify the accuracy of electrode placement. Receives: Procedure: Deep Brain Stimulation, DBS |
| LVA arm | Experimental | Patients in the LVA group underwent LVA surgery, followed by cervical ultrasound and CT to assess the anastomosis. Receives: Procedure: Deep cervical lymphatic-venous anastomosis, LVA |
| medication arm | Active comparator | Patients in the medication group received drug therapy only, without undergoing surgery. Receives: Drug: Recognized pharmacological treatments for AD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog)
The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) scale is widely used for evaluating the severity of AD. ADAS-Cog consists of 12 components including word recall, naming, command, constructional praxis, ideational praxis, orientation, word recognition, remembering test instructions, spoken language ability, word finding difficulty, comprehension of oral language, and attention. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation. ADAS-Cog score ranges from 0-75, with higher scores indicating more severe cognitive impairment.
Measured: changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery
Mini-Mental State Examination (MMSE) score
Mini-Mental State Examination (MMSE) is one of the most influential cognitive screening tools worldwide. It consists of five dimensions including orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points) and language and praxis (9 points). Educational attainment level-related dementia classification: illiterate: 5 points ≤ MMSE score ≤16 points; primary school: 8 points ≤ MMSE score ≤ 20 points; junior high school and above: 10 points ≤ MMSE score ≤ 24 points.
Measured: changes of baseline and month 1,month 3, month 6, month 9, month 12 month 15, month 18 after surgery
Clinical Dementia Rating(CDR) score
The Clinical Dementia Rating(CDR) is 5-point scale used to characterize six domains (memory, orientation, judgment \& problem solving, community affairs, home \& hobbies and personal care) of the cognitive and functional performance of the aged (in particular AD patients). Patients are rated on dementia severity: 0 = normal, 0.5 = questionable dementia; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia.
Measured: changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiqi Mao, Chinese PLA General Hospital
- Investigators
- Zhiqi Mao, Ph.D, Principal investigator, Chinese PLA General Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094438
- Sponsor's protocol ID
- ChinaPLAGH_CNT
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Patients With Severe Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07094438
- Acronym / sponsor ID
- ChinaPLAGH_CNT
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Jul 2025 (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.
To investigate the safety of deep brain stimulation (DBS) and cervical deep lymphoid-venous anastomosis (LVA) in the treatment of severe Alzheimer's disease (AD); to investigate the effectiveness of DBS and LVA in the treatment of severe AD, i.e., effects of deep brain stimulation on cognitive function, emotion and life quality in patients with severe AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DBS arm | Experimental | Procedure: Deep Brain Stimulation, DBSPatients in the DBS group underwent deep brain electrode implantation, followed by cranial MRI and CT to verify the accuracy of electrode placement. |
| LVA arm | Experimental | Procedure: Deep cervical lymphatic-venous anastomosis, LVAPatients in the LVA group underwent LVA surgery, followed by cervical ultrasound and CT to assess the anastomosis. |
| medication arm | Active comparator | Drug: Recognized pharmacological treatments for AD.Patients in the medication group received drug therapy only, without undergoing surgery. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meeting the diagnostic criteria for dementia formulated by the National Institute on Aging-Alzheimer's Association (NIA-AA).
- Clinical Dementia Rating (CDR) score of 3 points.
- Ability to ambulate independently or with the aid of a walker/cane.
- Adequate visual and auditory capacity to cooperate with examinations and treatment.
- Voluntary participation with written informed consent provided by both the subject and their legal guardian.
Key exclusion criteria (12 listed)
- Pre-existing abnormal brain structure (e.g., tumor, cerebral infarction, hydrocephalus, or intracranial hemorrhage).
- Comorbidity with other neurological disorders such as multiple sclerosis, epilepsy, or Parkinson's disease.
- Psychiatric disorders: e.g., anxiety, depression, other affective disorders, or drug-induced psychosis.
- Severe internal diseases, currently using respiratory/cardiovascular/anticonvulsant/psychotropic drugs, or clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular diseases, cancer, alcoholism, or substance addiction.
- Severe auditory or visual impairment.
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 |
|---|---|---|
| Deep Brain Stimulation, DBSDeep brain stimulation (DBS) is performed after preoperative MRI and CT images are fused in a planning system to determine the target and trajectory. Under general anesthesia, electrodes are precisely implanted into the fornix or nucleus basalis of Meynert using a stereotactic frame or neurosurgical robot. The electrodes are inserted through a burr hole in the patient's skull and connected to a pulse generator placed subcutaneously in the chest. Optimal stimulation parameters for Alzheimer's disease are not yet established. For fornix targets, settings are typically 3-3.5 V, ~130 Hz, 90 μs; for nucleus basalis targets, 2-4.5 V, 10-20 Hz, 90-150 μs, adjusted according to anatomical features and intraoperative responses. | Procedure or surgery | DBS arm |
| Deep cervical lymphatic-venous anastomosis, LVACervical deep lymphaticovenous anastomosis (LVA) microsurgically connects deep cervical lymphatic vessels to adjacent veins, promoting drainage of brain-derived amyloid-β and tau into the venous system and potentially alleviating Alzheimer's disease symptoms. The minimally invasive neck procedure involves small incisions and high-magnification suturing of lymphatics and veins with ultra-fine (11-0 or 12-0) sutures, creating multiple anastomoses to enhance brain lymphatic outflow. | Procedure or surgery | LVA arm |
| Recognized pharmacological treatments for AD.Patients in the medication group received only the currently recognized pharmacological treatments for AD, including Memantine Hydrochloride and Donepezil. | Drug | medication arm |
Primary outcome
The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog)
Time frame: changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery
The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) scale is widely used for evaluating the severity of AD. ADAS-Cog consists of 12 components including word recall, naming, command, constructional praxis, ideational praxis, orientation, word recognition, remembering test instructions, spoken language ability, word finding difficulty, comprehension of oral language, and attention. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation. ADAS-Cog score ranges from 0-75, with higher scores indicating more severe cognitive impairment.
Mini-Mental State Examination (MMSE) score
Time frame: changes of baseline and month 1,month 3, month 6, month 9, month 12 month 15, month 18 after surgery
Mini-Mental State Examination (MMSE) is one of the most influential cognitive screening tools worldwide. It consists of five dimensions including orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points) and language and praxis (9 points). Educational attainment level-related dementia classification: illiterate: 5 points ≤ MMSE score ≤16 points; primary school: 8 points ≤ MMSE score ≤ 20 points; junior high school and above: 10 points ≤ MMSE score ≤ 24 points.
Clinical Dementia Rating(CDR) score
Time frame: changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery
The Clinical Dementia Rating(CDR) is 5-point scale used to characterize six domains (memory, orientation, judgment \& problem solving, community affairs, home \& hobbies and personal care) of the cognitive and functional performance of the aged (in particular AD patients). Patients are rated on dementia severity: 0 = normal, 0.5 = questionable dementia; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia.
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 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Zhiqi Mao, Ph.D principal investigator
Chinese PLA General Hospita
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 Deep Brain Stimulation, DBS, Deep cervical lymphatic-venous anastomosis, LVA and Recognized pharmacological treatments for AD. in people with Alzheimer Disease, run by Chinese PLA General Hospital at 1 site in China.
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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. 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 China. 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 Zhiqi Mao, Ph.D (8618910155994, markmaoqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) (time frame: changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.