Effect of NeuroAD on Alzheimer Patients

NCT ID: NCT01825317

Last Updated: 2014-04-21

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-12-31

Brief Summary

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Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients.

Detailed Description

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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

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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NeuroAD

Treatment by the NeuroAD device, real treatment by synchronized TMS+cognitive training

Group Type ACTIVE_COMPARATOR

NeuroAD

Intervention Type DEVICE

synchronized TMS+COGNITIVE TRAINING

Sham NeuroAD

Sham TMS+cog, has the same sound and appearance, patients come for the same number of treatments and are exposed to the same procedure.

Group Type SHAM_COMPARATOR

Sham device

Intervention Type DEVICE

Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.

Interventions

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NeuroAD

synchronized TMS+COGNITIVE TRAINING

Intervention Type DEVICE

Sham device

Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.

Intervention Type DEVICE

Other Intervention Names

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NICE Control device

Eligibility Criteria

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Inclusion Criteria

1. Male or female age 60-90 years
2. Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria.
3. MMSE score 18 to 26
4. Adas-cog above 17
5. Physically acceptable for the study as confirmed by medical history and exam.
6. 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)
7. Agreement to participate in approximately 14 weeks during the study.
8. Normal or corrected to normal ability to see and to hear.
9. Korean as primary language
10. 8th grade education minimum

Exclusion Criteria

1. CDR 0 or 3
2. Severe agitation;
3. Mental retardation;
4. Patient lacking capacity to consent to study participation
5. Unstable medical condition;
6. Use of benzodiazepines or barbiturates during the study and preceding two weeks;
7. Pharmacological immunosuppression;
8. Participation in a clinical trial with any investigational agent within two weeks prior to study enrollment;
9. History of Epileptic Seizures or Epilepsy;
10. Contraindication for performing MRI scanning;
11. Contraindication for receiving TMS treatment according to a TMS questionnaire;
12. Pregnant women, and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
13. 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.
14. 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
15. 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
16. 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.
17. Patients with metal in the head, except the mouth (i.e. cochlear implants, implanted brain stimulators, aneurysm clips)
18. Patients with increased intracranial pressure
19. Cardiac pacemakers
20. Implanted neurostimulators
21. Implanted medication pumps
22. Intracardiac lines
23. Significant heart disease
24. Currently taking medication that lower the seizure threshold
25. Significant sleep deprivation and alcoholism
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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company: K The Power

UNKNOWN

Sponsor Role collaborator

Chungnam National University Hospital

OTHER

Sponsor Role collaborator

Neuronix Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chungnam national university hospital, Daejeon Geriatric Medical Center

Daejeon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NRX-KOR1

Identifier Type: -

Identifier Source: org_study_id

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