Effects of a NeuroAD System, for the Treatment of Alzheimer Disease

Neuronix

Status: Terminated

Conditions: Alzheimer's Disease

Treatments: Device: Sham TMS+Cog; Device: NeuroAD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02166827

NRX-LT1

Details and patient eligibility

About

To evaluate the long-term efficacy of the NeuroAD system

Full description

To evaluate the long-term efficacy of the NeuroAD system in improvement of mild- to moderate Alzheimer patients' cognitive function

Enrollment: 1 patient

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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. Physical clearance for study participation as evaluated by the clinician
5. Spouse, family member or professional caregiver agree and capable of taking care for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
6. Informed consent by the patient or by legally authorized person if appointed

Main Exclusion Criteria:

1. CDR 0, 0.5 or 3
2. Severe agitation
3. Mental retardation
4. History of Epileptic Seizures or Epilepsy
5. Contraindication for performing MRI scanning
6. Contraindication for receiving TMS treatment according to a TMS questionnaire
7. Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
8. Cardiac pacemakers
9. Implanted medication pumps
10. Intracardiac lines
11. Significant heart disease
12. Currently taking medication that lower the seizure threshold

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups

NeuroAD

Active Comparator group

Description:

NeuroAd Treatment, synchronized TMS and cognitive training stimulation

Treatment:

Device: NeuroAD

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 TMS+Cog