Clinical trial NCT01825330: Effect of NeuroAD on the Cognitive Function of Alzheimer Patients
Official title: Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Alzheimer's
TMS
Cognitive Training
NeuroAD
Lead sponsor: Neuronix Ltd
Sponsor class: INDUSTRY
First posted: 2013-04-05
Enrollment: 131
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Efficacy
timeFrame: 7 weeks
Secondary outcomes:
measure: Efficacy
timeFrame: 7 weeks
measure: Efficacy
timeFrame: 12 weeks
Other outcomes:
measure: Safety
timeFrame: 12 weeks
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute Clinic
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurology and Premiere Research Institute
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Brain Center
state: Nevada
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Center for Brain Health Lakewood Hospital
state: Ohio
city: Beer Yaakov
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Lou Ruvo Brain Center
name: Charlie Bernick, MD
role: PRINCIPAL_INVESTIGATOR
References: