Effect of NeuroAD on the Cognitive Function of Alzheimer Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01825330

Run by

Neuronix Ltd

People needed

131

Starts

2013-10-01

Expected to finish

2016-03-01

Last updated by the study team

2016-03-31

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Banner Sun Health Research Institute — Sun City, Arizona, United States
• ATP Clinical Research, Inc. — Costa Mesa, California, United States
• Miami Jewish Health Systems — Miami, Florida, United States
• Roskamp Institute Clinic — Sarasota, Florida, United States
• Palm Beach Neurology and Premiere Research Institute — West Palm Beach, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Cleveland Clinic Lou Ruvo Brain Center — Las Vegas, Nevada, United States
• NYU Langone Medical Center — New York, New York, United States
• Cleveland Clinic Center for Brain Health Lakewood Hospital — Cleveland, Ohio, United States
• Assaf Harofe Medical Center — Beer Yaakov, Israel

Full record on ClinicalTrials.gov

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