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Trial record 2 of 11 for:    Recruiting, Not yet recruiting, Available Studies | Alzheimer's Disease | brain stimulation

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

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ClinicalTrials.gov Identifier: NCT02253043
Recruitment Status : Recruiting
First Posted : October 1, 2014
Last Update Posted : October 14, 2016
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

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.

Condition or disease Intervention/treatment
Alzheimer's Disease Device: Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
Study Start Date : May 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Deep Brain Stimulation
DBS Implant and stimulation
Device: Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
PINS Stimulator System
Other Name: Deep Brain Stimulation Device

Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) [ Time Frame: 12 month ]
    Change from Baseline

Secondary Outcome Measures :
  1. Clinical Dementia Rating Scale [ Time Frame: 12 month ]
    Change from Baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253043

Contact: Jia Fumin, PhD +86 13811534875 pins_medical@163.com

China, Beijing
Beijing Tiantan Hospital Not yet recruiting
Beijing, Beijing, China, 100050
Contact: Jianguo Zhang, MD    010-67096611    Limuxin2011@163.com   
301 Hospatl Recruiting
Beijing, Beijing, China, 100853
Contact: Xinguang Yu, MD         
Contact: Zhipei Ling, MD         
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Beijing Tiantan Hospital
Study Chair: Li Luming, PhD Tsinghua University

Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02253043     History of Changes
Other Study ID Numbers: PINS-002
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: January 2016

Keywords provided by Beijing Pins Medical Co., Ltd:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders