Alzheimer's DiseaseNCT01825317
Effect of NeuroAD on Alzheimer Patients
A study testing NeuroAD in people with Alzheimer's Disease, run by Neuronix Ltd at 1 site in South Korea.
Trial summary
Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- NeuroAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Dec 2013
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 60-90 years
- Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria.
- MMSE score 18 to 26
- Adas-cog above 17
- Physically acceptable for the study as confirmed by medical history and exam.
- Spouse, family member or professional caregiver agree and capable of taking care and be responsible for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
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- Agreement to participate in approximately 14 weeks during the study.
- Normal or corrected to normal ability to see and to hear.
- Korean as primary language
- 8th grade education minimum
Who cannot join
- CDR 0 or 3
- Severe agitation;
- Mental retardation;
- Patient lacking capacity to consent to study participation
- Unstable medical condition;
- Use of benzodiazepines or barbiturates during the study and preceding two weeks;
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- Pharmacological immunosuppression;
- Participation in a clinical trial with any investigational agent within two weeks prior to study enrollment;
- History of Epileptic Seizures or Epilepsy;
- Contraindication for performing MRI scanning;
- Contraindication for receiving TMS treatment according to a TMS questionnaire;
- Pregnant women, and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
- Patients with personal history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, or multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness.
- Patients with depression, bipolar disorder or psychotic disorders or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study
- Alcoholism or drug addiction as defined by DSM-IV within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
- Patients treated with cholinesterase inhibitors, or memantine or Ginko-biloba will be allowed to participate, if the treatment has started at least 6 months previous to recruitment. The patients should keep their dose of medication during the whole trial as prior to study begin.
- Patients with metal in the head, except the mouth (i.e. cochlear implants, implanted brain stimulators, aneurysm clips)
- Patients with increased intracranial pressure
- Cardiac pacemakers
- Implanted neurostimulators
- Implanted medication pumps
- Intracardiac lines
- Significant heart disease
- Currently taking medication that lower the seizure threshold
- Significant sleep deprivation and alcoholism
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam national university hospital, Daejeon Geriatric Medical Center
Daejeon
About this study
Official title: Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients.
Read the detailed description
Synchronized TMS and cognitive training for the treatment of mild to moderate Alzheimer's patients. Treatment is delivered 5 days a week, for 6 weeks, visit is about an hour long.
Evaluation is by neuropsychological evaluation at 6 weeks.
- Conditions
- Alzheimer's Disease
- Being tested
- NeuroAD, Sham device
- Keywords
- Alzheimer's disease, TMS, NeuroAd, cognitive training, ADAS-Cog
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroADDevice
Also called NICE
synchronized TMS+COGNITIVE TRAINING
Sham deviceDevice
Also called Control device
Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.
| Study group | Role | What they receive |
|---|---|---|
| NeuroAD | Active comparator | Treatment by the NeuroAD device, real treatment by synchronized TMS+cognitive training Receives: Device: NeuroAD |
| Sham NeuroAD | Sham comparator | Sham TMS+cog, has the same sound and appearance, patients come for the same number of treatments and are exposed to the same procedure. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-Cog
Alzheimer's disease assessment scale - cognitive test
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronix Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- company: K The Power, Chungnam National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825317
- Sponsor's protocol ID
- NRX-KOR1
- Status last verified
- Apr 2014
- First submitted
- 2 Apr 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
- ClinicalTrials.gov ID
- NCT01825317
- Acronym / sponsor ID
- NRX-KOR1
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, TMS, NeuroAd, cognitive training, ADAS-Cog
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Neuronix LtdIndustry (pharma, biotech, devices)
- Collaborators
- company: K The Power, Chungnam National University Hospital
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Apr 2013 (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.
Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients.
Detailed description
Synchronized TMS and cognitive training for the treatment of mild to moderate Alzheimer's patients. Treatment is delivered 5 days a week, for 6 weeks, visit is about an hour long.
Evaluation is by neuropsychological evaluation at 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroAD | Active comparator | Device: NeuroADTreatment by the NeuroAD device, real treatment by synchronized TMS+cognitive training |
| Sham NeuroAD | Sham comparator | Device: Sham deviceSham TMS+cog, has the same sound and appearance, patients come for the same number of treatments and are exposed to the same procedure. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female age 60-90 years
- Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria.
- MMSE score 18 to 26
- Adas-cog above 17
- Physically acceptable for the study as confirmed by medical history and exam.
Key exclusion criteria (25 listed)
- CDR 0 or 3
- Severe agitation;
- Mental retardation;
- Patient lacking capacity to consent to study participation
- Unstable medical condition;
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 |
|---|---|---|
| NeuroADAlso: NICEsynchronized TMS+COGNITIVE TRAINING | Device | NeuroAD |
| Sham deviceAlso: Control deviceSham TMS+cog, has the same sound and appearance as the real device, delivers no energy. | Device | Sham NeuroAD |
Primary outcome
ADAS-Cog
Time frame: 6 weeks
Alzheimer's disease assessment scale - cognitive test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroAD in people with Alzheimer's Disease, run by Neuronix Ltd at 1 site in South Korea.
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 10 inclusion and 25 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: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-Cog (time frame: 6 weeks). 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 21 Apr 2014; AzTrials last refreshed its copy on 7 Nov 2026.