Alzheimer's Disease
Conditions
Keywords
TMS, Cognitive Stimulation, NeuroAD
Brief summary
To evaluate the long-term efficacy of the NeuroAD system
Detailed description
To evaluate the long-term efficacy of the NeuroAD system in improvement of mild- to moderate Alzheimer patients' cognitive function
Interventions
DEVICENeuroAD
Synchronized TMS and cognitive stimulation to 6 brain areas.
DEVICESham TMS+Cog
Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises.
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
Main 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. Physical clearance for study participation as evaluated by the clinician 5. Spouse, family member or professional caregiver agree and capable of taking care for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication) 6. Informed consent by the patient or by legally authorized person if appointed Main
Exclusion criteria
1. CDR 0, 0.5 or 3 2. Severe agitation 3. Mental retardation 4. History of Epileptic Seizures or Epilepsy 5. Contraindication for performing MRI scanning 6. Contraindication for receiving TMS treatment according to a TMS questionnaire 7. Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth 8. Cardiac pacemakers 9. Implanted medication pumps 10. Intracardiac lines 11. Significant heart disease 12. Currently taking medication that lower the seizure threshold
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 3 Months | Change from Baseline to 3 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 7 weeks | Change from Baseline to week 7 in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | 9 Months | Adverse events (AE's), including serious adverse events (SAEs) occurring at any time during the trial and follow-up |
Countries
Israel
Outcome results
None listed