Effect of NeuroAD on the Cognitive Function of Alzheimer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01825330|
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : March 31, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Device: TMS and cognitive stimulation Device: sham||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
- Efficacy [ Time Frame: 7 weeks ]Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
- 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.
- Safety [ Time Frame: 12 weeks ]Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up.
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, Learn About Clinical Studies.
|Ages Eligible for Study:||60 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825330
|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|
|Assaf Harofe Medical Center|
|Beer Yaakov, Israel|
|Principal Investigator:||Charlie Bernick, MD||Lou Ruvo Brain Center|
|Responsible Party:||Neuronix Ltd|
|Other Study ID Numbers:||
NRX - US4
|First Posted:||April 5, 2013 Key Record Dates|
|Last Update Posted:||March 31, 2016|
|Last Verified:||October 2015|
Central Nervous System Diseases
Nervous System Diseases