Effect of NeuroAD on the Cognitive Function of Alzheimer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neuronix Ltd
ClinicalTrials.gov Identifier:
NCT01825330
First received: March 24, 2013
Last updated: March 29, 2016
Last verified: October 2015
  Purpose
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.

Condition Intervention
Alzheimer's Disease
Device: TMS and cognitive stimulation
Device: sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients

Resource links provided by NLM:


Further study details as provided by Neuronix Ltd:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change

  • Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to week 12 in ADAS-Cog score.


Other Outcome Measures:
  • Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up.


Enrollment: 131
Study Start Date: October 2013
Study Completion Date: March 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NeuroAD
NeuroAD treatment, synchronized TMS and cognitive training stimulation
Device: TMS and cognitive stimulation
Synchronized TMS and cognitive stimulation to 6 brain areas.
Other Names:
  • NeuroAD
  • 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

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.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825330

Locations
United States, Arizona
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626
United States, Florida
Miami Jewish Health Systems
Miami, Florida, United States, 33137
Roskamp Institute Clinic
Sarasota, Florida, United States, 34243
Palm Beach Neurology and Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Nevada
Cleveland Clinic Lou Ruvo Brain Center
Las Vegas, Nevada, United States, 89106
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
United States, Ohio
Cleveland Clinic Center for Brain Health Lakewood Hospital
Cleveland, Ohio, United States, 44107
Israel
Assaf Harofe Medical Center
Beer Yaakov, Israel
Sponsors and Collaborators
Neuronix Ltd
Investigators
Principal Investigator: Charlie Bernick, MD Lou Ruvo Brain Center
  More Information

Additional Information:
Responsible Party: Neuronix Ltd
ClinicalTrials.gov Identifier: NCT01825330     History of Changes
Other Study ID Numbers: NRX - US4 
Study First Received: March 24, 2013
Last Updated: March 29, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Neuronix Ltd:
Alzheimer's Disease
Alzheimer's
TMS
Cognitive Training
NeuroAD

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 22, 2016