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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02253043
• Other study ID #: PINS-002
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2014
• Last updated: October 13, 2016
• Start date: May 2014
• Est. completion date: December 2018

Study information

• Verified date: January 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Jia Fumin, PhD
• Phone: +86 13811534875
• Email: pins_medical[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Device:
• Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
PINS Stimulator System

Locations

Country	Name	City	State
China	301 Hospatl	Beijing	Beijing
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)	Change from Baseline	12 month	Yes
Secondary	Clinical Dementia Rating Scale	Change from Baseline	12 month	Yes