Status:
UNKNOWN
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Collaborating Sponsors:
Beijing Tiantan Hospital
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Purpose: The purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment op...
Detailed Description
Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS Deep Brain Stimulation Device for 12 month.
Eligibility Criteria
Inclusion
- Subject is aged 40 to 80 years old;
- 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);
- Subject have received the diagnosis of AD within the past 2 years;
- Subject have a CDR of 0.5 or 1.0;
- Score between 20 and 28 on the Mini Mental State Examination
- have been taking a stable dose of cholinesterase inhibitors for a minimum of 6 months.
Exclusion
- Patients with hearing impairment;
- Failures of important organs and in severe conditions
- Be reluctant or disabled to receive neuropsychological assessments;
- Participate in other clinical trial;
- Has a life expectancy of \< 1 year.
- The investigator and/or enrollment review committee, would preclude participation in the study.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02253043
Start Date
May 1 2014
End Date
December 1 2018
Last Update
October 14 2016
Active Locations (2)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050
2
301 Hospatl
Beijing, Beijing Municipality, China, 100853