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Effect of NeuroAD on the Cognitive Function of Alzheimer Patients

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TMS and cognitive stimulation
sham
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 Alzheimer's Disease, Alzheimer's, TMS, Cognitive Training, NeuroAD

Eligibility Criteria

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

Sites / Locations

  • Banner Sun Health Research Institute
  • ATP Clinical Research, Inc.
  • Miami Jewish Health Systems
  • Roskamp Institute Clinic
  • Palm Beach Neurology and Premiere Research Institute
  • Beth Israel Deaconess Medical Center
  • Cleveland Clinic Lou Ruvo Brain Center
  • NYU Langone Medical Center
  • Cleveland Clinic Center for Brain Health Lakewood Hospital
  • Assaf Harofe Medical Center

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 week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive

Secondary Outcome Measures

Efficacy
Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change
Efficacy
Change from baseline to week 12 in ADAS-Cog score.

Full Information

First Posted
March 24, 2013
Last Updated
March 29, 2016
Sponsor
Neuronix Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01825330
Brief Title
Effect of NeuroAD on the Cognitive Function of Alzheimer Patients
Official Title
Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (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
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.
Detailed 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (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)
TMS and cognitive stimulation
Other Intervention Name(s)
NeuroAD, NICE
Intervention Description
Synchronized TMS and cognitive stimulation to 6 brain areas.
Intervention Type
Device
Intervention Name(s)
sham
Primary Outcome Measure Information:
Title
Efficacy
Description
Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Efficacy
Description
Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change
Time Frame
7 weeks
Title
Efficacy
Description
Change from baseline to week 12 in ADAS-Cog score.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Safety
Description
Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ADAS-Cog above 17 Physical clearance for study participation as evaluated by the clinician. 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) Agreement to participate in approximately 14 weeks during the study. Normal to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid). Fluent in English or Hebrew Minimum of 8th grade education 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: CDR 0, 0.5 or 3 Severe agitation Mental retardation Patient lacking capacity to consent to study participation Unstable medical condition Use of benzodiazepines or barbiturates 2 weeks prior to screening Pharmacological immunosuppression Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment History of Epileptic Seizures or Epilepsy Contraindication for performing MRI scanning Contraindication for receiving TMS treatment according to a TMS questionnaire Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study. 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 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 Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators, aneurysm clips) with the exception of metal implants in mouth 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. Patients with any signs or symptoms of increased intracranial pressure, as determined in a neurological exam. Cardiac pacemakers Implanted medication pumps Intracardiac lines Significant heart disease Currently taking medication that lower the seizure threshold. Patients on which TMS Motor Threshold cannot be found. Patient underwent TMS treatment in the past.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlie Bernick, MD
Organizational Affiliation
Lou Ruvo Brain Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Miami Jewish Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Roskamp Institute Clinic
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Palm Beach Neurology and Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Brain Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cleveland Clinic Center for Brain Health Lakewood Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Facility Name
Assaf Harofe Medical Center
City
Beer Yaakov
Country
Israel

12. IPD Sharing Statement

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

Learn more about this trial

Effect of NeuroAD on the Cognitive Function of Alzheimer Patients

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