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New treatment option for Alzheimers Disease
Official title Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD)
ClinicalTrials.gov ID: NCT07073066
What this study is testing
- What it's testing
- This multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with moderate-to-severe Alzheimer's Disease (AD).
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- Age 50-80 years, male or female.
- Diagnosed with AD according to NIA-AA criteria.
- Moderate-to-severe AD dementia, defined as Clinical Dementia Rating Scale Global Score (CDR-GS) ≥1.
- Mini-Mental State Examination (MMSE) score 10-20.
- The course of AD more than 6 months.
You likely can't join if
- Any neurological condition other than AD that may affect cognitive function, including stroke, Parkinson's disease, epilepsy, intracranial tumors or...
- Other causes of dementia, including vascular dementia, hereditary cerebral small vessel disease, vitamin deficiency, or any other etiology leading to...
- Previous evidence of severe stenosis (≥70%) in the middle cerebral artery and/or internal carotid artery.
- Presence of primary psychiatric disorders (such as schizophrenia, schizoaffective disorder, major depressive disorder, or bipolar disorder) rather...
- Severe neurological deficits in limb movement, language, vision, hearing, or consciousness, or any condition that the investigator determines may...
- History of drug or alcohol abuse or dependence.
See the full eligibility criteria
- Age 50-80 years, male or female.
- Diagnosed with AD according to NIA-AA criteria.
- Moderate-to-severe AD dementia, defined as Clinical Dementia Rating Scale Global Score (CDR-GS) ≥1.
- Mini-Mental State Examination (MMSE) score 10-20.
- The course of AD more than 6 months.
- If receiving an approved AD treatment, must be on a stable drug dose for at least 3 months prior to Baseline. AD Treatment-naïve people can be entered into the study.
- Have an identified caregiver (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The caregiver must accompany with the participant...
- Signed informed consent (from the participant or their relative, and the caregiver).
- Any neurological condition other than AD that may affect cognitive function, including stroke, Parkinson's disease, epilepsy, intracranial tumors or space-occupying lesions, traumatic brain injury, intracranial...
- Other causes of dementia, including vascular dementia, hereditary cerebral small vessel disease, vitamin deficiency, or any other etiology leading to dementia.
- Previous evidence of severe stenosis (≥70%) in the middle cerebral artery and/or internal carotid artery.
- Presence of primary psychiatric disorders (such as schizophrenia, schizoaffective disorder, major depressive disorder, or bipolar disorder) rather than psychiatric symptoms caused by AD.
- Severe neurological deficits in limb movement, language, vision, hearing, or consciousness, or any condition that the investigator determines may prevent the completion of cognitive function assessments.
- History of drug or alcohol abuse or dependence.
- History of malignant tumors or prior radiotherapy or surgery involving the head and neck.
- Major surgical procedures or severe head or body trauma within the past 30 days.
- Presence of other life-threatening conditions with an expected survival time of less than 2 years.
- Contraindications to head MRI (including cardiac pacemakers/defibrillators, ferromagnetic metal implants, etc.).
- Severe diseases or functional impairment of the heart, lungs, liver, kidneys, or other solid organs, making the patient unable to tolerate anesthesia or DC-LVA.
- Severe bleeding tendency (including but not limited to): platelet count \ 1.7.
- Requirement for long-term use of antithrombotic medications, with inability to discontinue them before surgery or potential risks associated with discontinuation.
- Uncontrolled persistent hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg).
- Co-infection with HIV or Treponema pallidum, or any uncontrolled infectious disease.
- Use of other investigational drugs or devices within 30 days prior to obtaining informed consent, or current participation in other treatment clinical studies.
- Pregnancy, lactation, potential for pregnancy, or plans for pregnancy during the study period.
- Immediate family members of the investigator (spouse, parents, children, or siblings), staff of the research institution or third-party organizations, or any other individuals with potential conflicts of interest...
The study team makes the final eligibility decision.
Where it's taking place
- Dongguan, Guangdong, China
- Guangdong, Guangzhou, China
- Zhengzhou, Henan, China
- Jinan, Shandong, China
- Jining, Shandong, China
- Ningbo, Zhejiang, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dongguan, Guangdong, China; Guangdong, Guangzhou, China; Zhengzhou, Henan, China; Jinan, Shandong, China; Jining, Shandong, China; Ningbo, Zhejiang, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.