Effect of NeuroAD on the Cognitive Function of Alzheimer Patients

Neuronix

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Device: TMS and cognitive stimulation; Device: sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT01825330

NRX - US4

Details and patient eligibility

About

The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The NeuroAD uses non-invasive stimulation of both magnetic and cognitive training.

Full description

The NeuroAD system is a combined system of Transcranial Magnetic Stimulation and cognitive training and is a non-invasive therapeutic system for the improvement of Alzheimer patients' cognitive function.

A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment or sham (placebo) Patient will attend the clinic 5 times a week for 6 weeks, approximately an hour every day for treatment/sham. The patient will be required to return to the clinic for follow-up.

Up to 150 patients will be enrolled in up to 10 clinical sites in the US and Israel.

Enrollment: 131 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. Physical clearance for study participation as evaluated by the clinician.
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 to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid).
9. Fluent in English or Hebrew
10. Minimum of 8th grade education
11. If medicated for AD, then use of cholinesterase inhibitors, memantine or Ginko-biloba for at least 3 months and on stable dose for at least 60 days prior to screening.

Exclusion criteria

1. CDR 0, 0.5 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 2 weeks prior to screening
7. Pharmacological immunosuppression
8. Participation in a clinical trial with any investigational agent within 6 months 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 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
14. 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
15. Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators, aneurysm clips) with the exception of metal implants in mouth
16. Patients with personal history of either any clinically defined medical disorder (which the investigator finds as interfering with the study) or any clinically defined neurological/psychiatric disorder (other than AD), including (but not limited to): epilepsy, stroke, brain lesions, substance abuse, vitamin B12 deficiency, abnormal thyroid function, cerebrovascular condition, other neurodegenerative disease, head trauma, multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness.
17. Patients with any signs or symptoms of increased intracranial pressure, as determined in a neurological exam.
18. Cardiac pacemakers
19. Implanted medication pumps
20. Intracardiac lines
21. Significant heart disease
22. Currently taking medication that lower the seizure threshold.
23. Patients on which TMS Motor Threshold cannot be found.
24. Patient underwent TMS treatment in the past.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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131 participants in 2 patient groups

NeuroAD

Active Comparator group

Description:

NeuroAD treatment, synchronized TMS and cognitive training stimulation

Treatment:

Device: TMS and cognitive stimulation

Sham TMS+Cog

Sham Comparator group

Description:

Sham device, has the same appearance and sound as the real device, combined with sham cognitive exercises. Patients come for the same number of sessions, delivers no real stimulation or cognitive training.

Treatment:

Device: sham