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Effect of NeuroAD on the Cognitive Function of Alzheimer Patients

Sponsor
Neuronix Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT01825330
Collaborator
(none)
131
Enrollment
10
Locations
2
Arms
29
Duration (Months)
13.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TMS and cognitive stimulation
  • Device: sham
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy [7 weeks]

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

    Secondary Outcome Measures

    1. Efficacy [7 weeks]

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

    2. Efficacy [12 weeks]

      Change from baseline to week 12 in ADAS-Cog score.

    Other Outcome Measures

    1. Safety [12 weeks]

      Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Banner Sun Health Research Institute Sun City Arizona United States 85351
    2 ATP Clinical Research, Inc. Costa Mesa California United States 92626
    3 Miami Jewish Health Systems Miami Florida United States 33137
    4 Roskamp Institute Clinic Sarasota Florida United States 34243
    5 Palm Beach Neurology and Premiere Research Institute West Palm Beach Florida United States 33407
    6 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    7 Cleveland Clinic Lou Ruvo Brain Center Las Vegas Nevada United States 89106
    8 NYU Langone Medical Center New York New York United States 10016
    9 Cleveland Clinic Center for Brain Health Lakewood Hospital Cleveland Ohio United States 44107
    10 Assaf Harofe Medical Center Beer Yaakov Israel

    Sponsors and Collaborators

    • Neuronix Ltd

    Investigators

    • Principal Investigator: Charlie Bernick, MD, Lou Ruvo Brain Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Neuronix Ltd
    ClinicalTrials.gov Identifier:
    NCT01825330
    Other Study ID Numbers:
    • NRX - US4
    First Posted:
    Apr 5, 2013
    Last Update Posted:
    Mar 31, 2016
    Last Verified:
    Oct 1, 2015
    Keywords provided by Neuronix Ltd
    Alzheimer's Disease
    Alzheimer's
    TMS
    Cognitive Training
    NeuroAD
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Mar 31, 2016