Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Pins Medical Co., Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS of the fornix, power on | Experimental |
| |
| DBS of the NbM, power on | Experimental |
| |
| DBS of the fornix, power off | Sham Comparator |
| |
| DBS of the NbM, power off | Sham Comparator |
| |
| Control group | No Intervention | The patients are going to prescribe stable dosage of donepezil during observation period without surgical interference. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBS of the fornix, power on | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months (from 1 month to 13 month after implantation) |
| Measure | Description | Time Frame |
|---|---|---|
| Neuroplasticity outcome | Protection of hippocampal volume revealed by magnetic resonance imaging (MRI). | 12 months (from 1 month to 13 month after implantation) |
| Neuroplasticity outcome | Improved cerebral metabolic level revealed by FDG positron emission tomography(PET) imaging. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo-Guang Zhao, M.D. | Contact | +86-010-63037023 | ggzhao@vip.sina.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University. | Recruiting | Beijing | 100053 | China |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| DBS of the NbM, power on | Device | 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 off | Device | 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 |
|
| DBS of the NbM, power off | Device | 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 |
|
| 12 months (from 1 month to 13 month after implantation) |
| Cognitive outcome | 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). | 12 months (from 1 month to 13 month after implantation) |
| Functional outcome | 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). | 12 months (from 1 month to 13 month after implantation) |
| Safety outcome | Device/therapy related side effects or complications such as mortality an morbidity. | 12 months (from 1 month to 13 month after implantation) |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |