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

Not Applicable

• Conditions: Alzheimer's Disease
• Interventions: Device: Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)

• Registration Number: NCT02253043
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-01
• Status Verified: 2016-01
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)	DBS Implant and stimulation

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)	12 month	Change from Baseline

Secondary Outcome Measures

Name	Time	Method
Clinical Dementia Rating Scale	12 month	Change from Baseline

Trial Locations

Locations (2)

301 Hospatl; 🇨🇳 Beijing, Beijing, China

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China