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

October 13, 2016 updated by: Beijing Pins Medical Co., Ltd
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS Deep Brain Stimulation Device for 12 month.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Not yet recruiting
        • Beijing Tiantan Hospital
      • Beijing, Beijing, China, 100853
        • Recruiting
        • 301 Hospatl
        • Contact:
          • Xinguang Yu, MD
        • Contact:
          • Zhipei Ling, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Deep Brain Stimulation
DBS Implant and stimulation
Device: Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
PINS Stimulator System
Other Names:
  • Deep Brain Stimulation Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)
Time Frame: 12 month
Change from Baseline
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Dementia Rating Scale
Time Frame: 12 month
Change from Baseline
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Collaborators

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (ESTIMATE)

October 1, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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