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The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is aged 40 to 80 years old;
  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:

  1. Patients with hearing impairment;
  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.

Sites / Locations

  • Beijing Tiantan Hospital
  • 301 HospatlRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep Brain Stimulation

Arm Description

DBS Implant and stimulation

Outcomes

Primary Outcome Measures

Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)
Change from Baseline

Secondary Outcome Measures

Clinical Dementia Rating Scale
Change from Baseline

Full Information

First Posted
September 25, 2014
Last Updated
October 13, 2016
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02253043
Brief Title
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
Official Title
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.
Detailed Description
Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS Deep Brain Stimulation Device for 12 month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
DBS Implant and stimulation
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
Other Intervention Name(s)
Deep Brain Stimulation Device
Intervention Description
PINS Stimulator System
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)
Description
Change from Baseline
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Clinical Dementia Rating Scale
Description
Change from Baseline
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Fumin, PhD
Phone
+86 13811534875
Email
pins_medical@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Luming, PhD
Organizational Affiliation
Tsinghua University
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianguo Zhang, MD
Phone
010-67096611
Email
Limuxin2011@163.com
Facility Name
301 Hospatl
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinguang Yu, MD
First Name & Middle Initial & Last Name & Degree
Zhipei Ling, MD

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease

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