The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
NCT ID: NCT02253043
Last Updated: 2016-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2014-05-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Deep Brain Stimulation
DBS Implant and stimulation
Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
PINS Stimulator System
Interventions
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Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
PINS Stimulator System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject with AD diagnosed according to the criteria for probable AD as defined by the National Institute of Neurological Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA);
3. Subject have received the diagnosis of AD within the past 2 years;
4. Subject have a CDR of 0.5 or 1.0;
5. Score between 20 and 28 on the Mini Mental State Examination
6. have been taking a stable dose of cholinesterase inhibitors for a minimum of 6 months.
Exclusion Criteria
2. Failures of important organs and in severe conditions
3. Be reluctant or disabled to receive neuropsychological assessments;
4. Participate in other clinical trial;
5. Has a life expectancy of \< 1 year.
6. The investigator and/or enrollment review committee, would preclude participation in the study.
40 Years
80 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Beijing Pins Medical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Li Luming, PhD
Role: STUDY_CHAIR
Tsinghua University
Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
301 Hospatl
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xinguang Yu, MD
Role: primary
Zhipei Ling, MD
Role: backup
Other Identifiers
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PINS-002
Identifier Type: -
Identifier Source: org_study_id
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