Alzheimer's Disease
Conditions
Keywords
Alzheimer's Disease, Alzheimer's, TMS, Cognitive Training, NeuroAD
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.
Interventions
DEVICETMS and cognitive stimulation
Synchronized TMS and cognitive stimulation to 6 brain areas.
DEVICEsham
Sponsors
Neuronix Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 7 weeks | Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 7 weeks | Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | 12 weeks | Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up. |
Countries
Israel, United States
Outcome results
None listed