Alzheimer Disease
Conditions
Brief summary
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.
Interventions
DEVICEDBS of the fornix, power on
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
DEVICEDBS of the NbM, power on
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
DEVICEDBS of the fornix, power off
DBS of bilateral columns of the fornix is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation. DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
DEVICEDBS of the NbM, power off
DBS of bilateral NbMs is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation. DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
Sponsors
Beijing Pins Medical Co., Ltd
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive outcome | 12 months (from 1 month to 13 month after implantation) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuroplasticity outcome | 12 months (from 1 month to 13 month after implantation) | Protection of hippocampal volume revealed by magnetic resonance imaging (MRI). |
| Cognitive outcome | 12 months (from 1 month to 13 month after implantation) | Improvement of cognitive function evaluated by Clinical Dementia Rating Scale sum of the boxes (CDR-SB). CDR-SB scale range: 0-18; (0 represents normal cognition, the higher the score, the worse the cognitive function). |
| Functional outcome | 12 months (from 1 month to 13 month after implantation) | Improvement of life quality according to Activities of Daily Living (ADL) scale. ADL scale range: 20-80 (20 represents normal life ability, the higher the score, the worse the life ability). |
| Safety outcome | 12 months (from 1 month to 13 month after implantation) | Device/therapy related side effects or complications such as mortality an morbidity. |
Countries
China
Contacts
Primary ContactGuo-Guang Zhao, M.D.
Outcome results
None listed