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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02253043

Enrollment

Registered

2014-10-01

Start date

2014-05-31

Completion date

2018-12-31

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease

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.

Interventions

DEVICEDeep Brain Stimulation (Beijing PINS Medical Co., Ltd)

PINS Stimulator System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Clinical Dementia Rating Scale	12 month	Change from Baseline

Countries

China

Contacts

Primary ContactJia Fumin, PhD

pins_medical@163.com+86 13811534875

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026