Alzheimer's DiseaseNCT02253043
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
A study testing Deep Brain Stimulation (Beijing PINS Medical Co., Ltd) in people with Alzheimer's Disease, run by Beijing Pins Medical Co., Ltd at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- May 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Jianguo Zhang, MD, 010-67096611, Limuxin2011@163.com
- Recruiting
301 Hospatl
Beijing, Beijing Municipality, 100853
Xinguang Yu, MD
Zhipei Ling, MD
About this study
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.
Read the detailed description
Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS Deep Brain Stimulation Device for 12 month.
- Conditions
- Alzheimer's Disease
- Being tested
- Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
- Keywords
- Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)Device
Also called Deep Brain Stimulation Device
PINS Stimulator System
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | DBS Implant and stimulation Receives: Device: Deep Brain Stimulation (Beijing PINS Medical Co., Ltd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)
Change from Baseline
Measured: 12 month
Secondary outcomes (1)
Clinical Dementia Rating Scale
Change from Baseline
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Li Luming, PhD, Study chair, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253043
- Sponsor's protocol ID
- PINS-002
- Status last verified
- Jan 2016
- First submitted
- 25 Sep 2014
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02253043
- Acronym / sponsor ID
- PINS-002
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Study start
- May 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Device: Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)DBS Implant and stimulation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)Also: Deep Brain Stimulation DevicePINS Stimulator System | Device | Deep Brain Stimulation |
Primary outcome
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)
Time frame: 12 month
Change from Baseline
1 secondary outcome
Clinical Dementia Rating Scale
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Luming, PhD study chair
Tsinghua University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation (Beijing PINS Medical Co., Ltd) in people with Alzheimer's Disease, run by Beijing Pins Medical Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Fumin, PhD (+86 13811534875, pins_medical@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.