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

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
NeuroAD
Sham TMS+Cog
Sponsored by
Neuronix Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring TMS, Cognitive Stimulation, NeuroAD

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shaare Zedek

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

NeuroAD

Sham TMS+Cog

Arm Description

NeuroAd Treatment, synchronized TMS and cognitive training stimulation

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.

Outcomes

Primary Outcome Measures

Efficacy
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

Efficacy
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
Efficacy
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
Efficacy
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

Full Information

First Posted
June 15, 2014
Last Updated
March 30, 2017
Sponsor
Neuronix Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02166827
Brief Title
Effects of a NeuroAD System, for the Treatment of Alzheimer Disease
Official Title
Effects of a NeuroAD System, for the Treatment of Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Administrative decision
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuronix Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
TMS, Cognitive Stimulation, NeuroAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NeuroAD
Arm Type
Active Comparator
Arm Description
NeuroAd Treatment, synchronized TMS and cognitive training stimulation
Arm Title
Sham TMS+Cog
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
NeuroAD
Other Intervention Name(s)
NICE
Intervention Description
Synchronized TMS and cognitive stimulation to 6 brain areas.
Intervention Type
Device
Intervention Name(s)
Sham TMS+Cog
Intervention Description
Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises.
Primary Outcome Measure Information:
Title
Efficacy
Description
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
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Efficacy
Description
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
Time Frame
7 weeks
Title
Efficacy
Description
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
Time Frame
6 Months
Title
Efficacy
Description
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
Time Frame
9 Months
Other Pre-specified Outcome Measures:
Title
Safety
Description
Adverse events (AE's), including serious adverse events (SAEs) occurring at any time during the trial and follow-up
Time Frame
9 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Male or female age 60-90 years Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria MMSE score 18 to 26 Physical clearance for study participation as evaluated by the clinician 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) Informed consent by the patient or by legally authorized person if appointed Main Exclusion Criteria: CDR 0, 0.5 or 3 Severe agitation Mental retardation History of Epileptic Seizures or Epilepsy Contraindication for performing MRI scanning Contraindication for receiving TMS treatment according to a TMS questionnaire 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 Cardiac pacemakers Implanted medication pumps Intracardiac lines Significant heart disease Currently taking medication that lower the seizure threshold
Facility Information:
Facility Name
Shaare Zedek
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel

12. IPD Sharing Statement

Links:
URL
http://neuronixmedical.com/
Description
Sponsor's website

Learn more about this trial

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

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