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

Not Applicable

Terminated

• Conditions: Alzheimer's Disease

• Registration Number: NCT02166827
• Lead Sponsor: Neuronix Ltd

Brief Summary

To evaluate the long-term efficacy of the NeuroAD system

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-06-15
• Study First Submitted QC: 2014-06-15
• Study First Posted: 2014-06-18
• Study Start: 2014-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy	3 Months	Change from Baseline to 3 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change

Secondary Outcome Measures

Name	Time	Method
Efficacy	9 Months	Change from Baseline to 9 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change

Trial Locations

Locations (1)

Shaare Zedek; 🇮🇱 Jerusalem, Israel