The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
1 other identifier
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 25, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 14, 2016
January 1, 2016
4.6 years
September 25, 2014
October 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)
Change from Baseline
12 month
Secondary Outcomes (1)
Clinical Dementia Rating Scale
12 month
Study Arms (1)
Deep Brain Stimulation
EXPERIMENTALDBS Implant and stimulation
Interventions
PINS Stimulator System
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Pins Medical Co., Ltdlead
- Beijing Tiantan Hospitalcollaborator
Study Sites (2)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050, China
301 Hospatl
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Li Luming, PhD
Tsinghua University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2014
First Posted
October 1, 2014
Study Start
May 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 14, 2016
Record last verified: 2016-01