A Pilot Study of Deep Cervical Lymphatic-venous Anastomosis in the Treatment of Alzheimer's Disease

NCT06448442 | Not Yet Recruiting

• 1 other identifier: 2024-0429
• Study Type: observational
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

Alzheimer's disease (AD) is the most prevalent form of dementia, affecting 3-4% of the population over a lifetime. It's characterized by abnormal Amyloid-beta (Aβ) and tau protein expression and accumulation in the central nervous system, leading to amyloid plaques and neurofibrillary tangles. While current treatments can slow cognitive decline, there's no cure. The discovery of the "glymphatic-meningeal lymphatic" system has shed new light on cerebrospinal fluid circulation, showing it has a similar interstitial fluid system to peripheral lymphatic circulation. This system helps clear waste and transport nutrients in the brain, known as the glymphatic phenomenon. The deep cervical lymph nodes, part of this system, are crucial for cerebrospinal fluid drainage and are linked to the clearance of AD-related proteins. Aging and inflammation can impair deep cervical lymph node function, increasing cerebrospinal fluid drainage pressure and potentially contributing to AD progression. Lymphatic anastomosis, a surgical technique used for lymphedema and other conditions, is being explored as a potential treatment to alleviate neurodegenerative disease by reducing cerebrospinal fluid pressure and clearing metabolic waste.

Conditions

Safety Issues; Feasibility; Therapeutic Value

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment scale

  ADAS-cog14; range 0 to 90

  1 week pre-suregery and 1 week, 1 month and 3 month after suregery

Secondary Outcomes (2)

• Alzheimer's Disease Composite Score

  1 week pre-suregery and 1 week, 1 month and 3 month after suregery

• Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment

  1 week pre-suregery and 1 week, 1 month and 3 month after suregery

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Alzheimer's disease

You may qualify if:

• a. aged 50-90 years (\> or equal to 50 years old, \< or equal to 90 years old) were evaluated as Alzheimer's disease group according to the 2018 NIA-AA diagnostic criteria; B. signed by the patient or family informed consent; c. Patients with mild or moderate disease, 11≤MMSE≤26; d. Subjects with primary school education or above can complete the prescribed scale evaluation; The diagnosis of AD was confirmed by e.PET or cerebrospinal fluid examination

You may not qualify if:

• a. any other disease that can cause cognitive impairment (e.g., dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease dementia, etc.), intracranial mass impairing cognition, history of traumatic brain injury, normal pressure hydrocephalus, history of clinically significant cerebrovascular disease; b. Excluding other diseases affecting the nervous system, including nervous system infection, epilepsy, and systemic diseases affecting the function of the nervous system; c. Inability to cooperate with cognitive testing; d. Presence of contraindications to MRI examination (e.g., pacemakers, stents, claustrophobia, severe psychiatric symptoms, etc.).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 7, 2024

Record last verified: 2024-06