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

March 30, 2017 updated by: Neuronix Ltd

Effects of a NeuroAD System, for the Treatment of Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study

To evaluate the long-term efficacy of the NeuroAD system

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 9103102
        • Shaare Zedek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NeuroAD
NeuroAd Treatment, synchronized TMS and cognitive training stimulation
Device: NeuroAD
Synchronized TMS and cognitive stimulation to 6 brain areas.
Other Names:
  • NICE
Sham Comparator: Sham TMS+Cog
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.
Device: Sham TMS+Cog
Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 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
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 7 weeks
Change from Baseline to week 7 in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change
7 weeks
Efficacy
Time Frame: 6 Months
Change from Baseline to 6 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change
6 Months
Efficacy
Time Frame: 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
9 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 9 Months
Adverse events (AE's), including serious adverse events (SAEs) occurring at any time during the trial and follow-up
9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuronix Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 15, 2014

First Submitted That Met QC Criteria

June 15, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRX-LT1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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