Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, TMS, NeuroAd, cognitive training, ADAS-Cog
Brief summary
Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients.
Detailed description
Synchronized TMS and cognitive training for the treatment of mild to moderate Alzheimer's patients. Treatment is delivered 5 days a week, for 6 weeks, visit is about an hour long. Evaluation is by neuropsychological evaluation at 6 weeks.
Interventions
DEVICENeuroAD
synchronized TMS+COGNITIVE TRAINING
DEVICESham device
Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.
Sponsors
company: K The Power
Chungnam National University Hospital
Neuronix Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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. Physically acceptable for the study as confirmed by medical history and exam. 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 or corrected to normal ability to see and to hear. 9. Korean as primary language 10. 8th grade education minimum
Exclusion criteria
1. CDR 0 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 during the study and preceding two weeks; 7. Pharmacological immunosuppression; 8. Participation in a clinical trial with any investigational agent within two weeks 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 personal history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, or multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness. 14. 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 15. 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 16. Patients treated with cholinesterase inhibitors, or memantine or Ginko-biloba will be allowed to participate, if the treatment has started at least 6 months previous to recruitment. The patients should keep their dose of medication during the whole trial as prior to study begin. 17. Patients with metal in the head, except the mouth (i.e. cochlear implants, implanted brain stimulators, aneurysm clips) 18. Patients with increased intracranial pressure 19. Cardiac pacemakers 20. Implanted neurostimulators 21. Implanted medication pumps 22. Intracardiac lines 23. Significant heart disease 24. Currently taking medication that lower the seizure threshold 25. Significant sleep deprivation and alcoholism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADAS-Cog | 6 weeks | Alzheimer's disease assessment scale - cognitive test |
Countries
South Korea
Outcome results
None listed