Status:
UNKNOWN
Fornix and NbM as Targets of Stimulation In Alzheimer's Disease
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
Beijing Pins Medical Co., Ltd
Conditions:
Alzheimer Disease
Eligibility:
All Genders
45-75 years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- Subjects with informed consent;
- 45-75 years of age;
- At least 6 years of education;
- AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines (McKhann et al., 2011);
- Clinical Dementia Rating Scale (CDR): 1.0-2.0;
- Positive findings with amyloid PET imaging;
- Stable prescription of donepezil (5mg, qd) for at least 3 months, and without any intentions to modify the dosage during the observation period.
Exclusion
- Fazekas scale\>2;
- Neuropsychiatric inventory (NPI) total score ≥10, or any subdomain≥4；
- Modified Hachinski ischemic score\>4；
- Young Mania Rating Scale\>11(Young, Biggs, Ziegler, \& Meyer, 1978);
- Any suicidal tendencies in recent 2 years;
- Cornell Scale for Depression and Dementia\>10;
- Familial AD;
- Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;
- Surgical history of the central nervous system;
- Severe cardiovascular/pulmonary disorders.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03352739
Start Date
December 1 2017
End Date
December 1 2020
Last Update
January 11 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Xuanwu Hospital, Capital Medical University.
Beijing, China, 100053