Alzheimer Disease Clinical Trial
— FANTASIAOfficial title:
A Randomized Controlled Study of 12 Months to Evaluate the Safety and Efficacy of Deep Brain Stimulation(DBS) to the Fornix & Meynert Nucleus(NbM) in Patients With Mild to Moderate Alzheimer's Disease(AD)
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital, Capital Medical University. | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing | Beijing Pins Medical Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Secondary | Neuroplasticity outcome | Protection of hippocampal volume revealed by magnetic resonance imaging (MRI). | 12 months (from 1 month to 13 month after implantation) | |
Secondary | Neuroplasticity outcome | Improved cerebral metabolic level revealed by FDG positron emission tomography(PET) imaging. | 12 months (from 1 month to 13 month after implantation) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Safety outcome | Device/therapy related side effects or complications such as mortality an morbidity. | 12 months (from 1 month to 13 month after implantation) |
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