Fornix and NbM as Targets of Stimulation In Alzheimer's Disease

Xuanwu Hospital, Beijing30 enrolled

Overview

The primary goal of this study is to evaluate the efficacy and safety of the DBS to the fornix/NbM among patients who are diagnosed as AD according to a series of evaluations including cerebrospinal fluid (CSF) biomarkers and molecular imaging examinations; The secondary goal is to compare the efficacy among the two treatment groups of different targets.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alzheimer Disease

Interventions

DBS of the fornix, power onDEVICE

DBS of bilateral columns of the fornix is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on . DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead

DBS of the NbM, power onDEVICE

DBS of bilateral NbMs is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on . DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead

DBS of the fornix, power offDEVICE

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects with informed consent; 2. 45-75 years of age; 3. At least 6 years of education; 4. AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines (McKhann et al., 2011); 5. Clinical Dementia Rating Scale (CDR): 1.0-2.0; 6. Positive findings with amyloid PET imaging; 7. Stable prescription of donepezil (5mg, qd) for at least 3 months, and without any intentions to modify the dosage during the observation period. Exclusion Criteria: 1. Fazekas scale\>2; 2. Neuropsychiatric inventory (NPI) total score ≥10, or any subdomain≥4； 3. Modified Hachinski ischemic score\>4； 4. Young Mania Rating Scale\>11(Young, Biggs, Ziegler, \& Meyer, 1978); 5. Any suicidal tendencies in recent 2 years; 6. Cornell Scale for Depression and Dementia\>10; 7. Familial AD; 8. Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome; 9. Surgical history of the central nervous system; 10. Severe cardiovascular/pulmonary disorders.

Locations (1)

Xuanwu Hospital, Capital Medical University.

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Cognitive outcome

Cognitive function measured by Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 13-items version). ADAS-cog 13 scale range: 0-80; (Higher value represents a worse outcome)