Effect of NeuroAD on Alzheimer Patients

Neuronix

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Device: NeuroAD; Device: Sham device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01825317

NRX-KOR1

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups

NeuroAD

Active Comparator group

Description:

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

Treatment:

Device: NeuroAD

Sham NeuroAD

Sham Comparator group

Description:

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

Treatment:

Device: Sham device