Effect of NeuroAD on the Cognitive Function of Alzheimer Patients

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

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
Alzheimer's Disease	Device: TMS and cognitive stimulation; Device: sham	Not Applicable

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 (Clinical Trial)
• 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: October 2013
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: March 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 [ Time Frame: 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 [ Time Frame: 7 weeks ]
   Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change
2. Efficacy [ Time Frame: 12 weeks ]
   Change from baseline to week 12 in ADAS-Cog score.

Other Outcome Measures:

1. Safety [ Time Frame: 12 weeks ]
   Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up.

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Sponsor's website 

• Responsible Party: Neuronix Ltd
• ClinicalTrials.gov Identifier: NCT01825330
• Other Study ID Numbers: NRX - US4
• First Posted: April 5, 2013
• Last Update Posted: March 31, 2016
• Last Verified: October 2015

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