Effect of NeuroAD on Alzheimer Patients

Alzheimer's Disease Clinical Trial

Official title:

Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825317
• Other study ID #: NRX-KOR1
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: April 17, 2014
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Neuronix Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Device:
• NeuroAD
synchronized TMS+COGNITIVE TRAINING
• Sham device
Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.

Locations

Country	Name	City	State
Korea, Republic of	Chungnam national university hospital, Daejeon Geriatric Medical Center	Daejeon

Sponsors (3)

Lead Sponsor	Collaborator
Neuronix Ltd	Chungnam National University Hospital, company: K The Power

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADAS-Cog	Alzheimer's disease assessment scale - cognitive test	6 weeks	No