Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Patients With Severe Alzheimer's Disease

NCT07094438 Phase 1 RECRUITING

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.

Details

Lead sponsor	Chinese PLA General Hospital
Phase	Phase 1
Status	RECRUITING
Enrolment	98
Start date	2025-01-01
Completion	2027-07

Conditions

• Alzheimer Disease

Interventions

• Deep Brain Stimulation, DBS
• Deep cervical lymphatic-venous anastomosis, LVA
• Recognized pharmacological treatments for AD.

Primary outcomes

• The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) — 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 — 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 — 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.

Countries

China