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

NCT ID: NCT02253043

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Deep Brain Stimulation

DBS Implant and stimulation

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

PINS Stimulator System

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

PINS Stimulator System

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Deep Brain Stimulation Device

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Li Luming, PhD

Role: STUDY_CHAIR

Tsinghua University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

301 Hospatl

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jia Fumin, PhD

Role: CONTACT

+86 13811534875

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jianguo Zhang, MD

Role: primary

010-67096611

Xinguang Yu, MD

Role: primary

Zhipei Ling, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PINS-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PSA Versus STN DBS for DT
NCT06752434 RECRUITING NA