Trial record 2 of 11 for:    Open Studies | Alzheimer's Disease | brain stimulation

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Beijing Pins Medical Co., Ltd
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier:
NCT02253043
First received: September 25, 2014
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Alzheimer's Disease
Device: Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Beijing Pins Medical Co., Ltd:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    Change from Baseline


Secondary Outcome Measures:
  • Clinical Dementia Rating Scale [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    Change from Baseline


Estimated Enrollment: 10
Study Start Date: September 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02253043

Contacts
Contact: Jia Fumin, PhD +86 010-59361265 pins_medical@163.com

Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Beijing Tiantan Hospital
Investigators
Study Chair: Li Luming, PhD Tsinghua University
  More Information

No publications provided

Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02253043     History of Changes
Other Study ID Numbers: PINS-002
Study First Received: September 25, 2014
Last Updated: September 30, 2014
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on May 25, 2015