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Trial record 1 of 1 for:    NCT 01825330
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Effect of NeuroAD on the Cognitive Function of Alzheimer Patients

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ClinicalTrials.gov Identifier: NCT01825330
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Neuronix Ltd

Tracking Information
First Submitted Date  ICMJE March 24, 2013
First Posted Date  ICMJE April 5, 2013
Last Update Posted Date March 31, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
Efficacy [ Time Frame: 7 weeks ]
Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2013)
Adas-cog [ Time Frame: 6 weeks ]
Adas-cog is the Alzheimer's disease assessment scale - cognitive
Change History Complete list of historical versions of study NCT01825330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
  • Efficacy [ Time Frame: 7 weeks ]
    Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change
  • Efficacy [ Time Frame: 12 weeks ]
    Change from baseline to week 12 in ADAS-Cog score.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 28, 2013)
Safety [ Time Frame: 12 weeks ]
Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of NeuroAD on the Cognitive Function of Alzheimer Patients
Official Title  ICMJE Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Device: TMS and cognitive stimulation
    Synchronized TMS and cognitive stimulation to 6 brain areas.
    Other Names:
    • NeuroAD
    • NICE
  • Device: sham
Study Arms  ICMJE
  • Active Comparator: NeuroAD
    NeuroAD treatment, synchronized TMS and cognitive training stimulation
    Intervention: Device: TMS and cognitive stimulation
  • 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.
    Intervention: Device: sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2016)
131
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2013)
18
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01825330
Other Study ID Numbers  ICMJE NRX - US4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neuronix Ltd
Study Sponsor  ICMJE Neuronix Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charlie Bernick, MD Lou Ruvo Brain Center
PRS Account Neuronix Ltd
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP