Effect of NeuroAD on the Cognitive Function of 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: Active, not recruiting

Administrative data

• NCT number: NCT01825330
• Other study ID #: NRX - US4
• Status: Active, not recruiting
• Phase: N/A
• First received: March 24, 2013
• Last updated: October 8, 2015
• Start date: October 2013
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: Neuronix Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• 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. 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.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Device:
• TMS and cognitive stimulation
Synchronized TMS and cognitive stimulation to 6 brain areas.
• sham

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Beer Yaakov
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cleveland Clinic Center for Brain Health Lakewood Hospital	Cleveland	Ohio
United States	ATP Clinical Research, Inc.	Costa Mesa	California
United States	Cleveland Clinic Lou Ruvo Brain Center	Las Vegas	Nevada
United States	Miami Jewish Health Systems	Miami	Florida
United States	NYU Langone Medical Center	New York	New York
United States	Roskamp Institute Clinic	Sarasota	Florida
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Palm Beach Neurology and Premiere Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Neuronix Ltd

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up.	12 weeks	Yes
Primary	Efficacy	Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive	7 weeks	No
Secondary	Efficacy	Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change	7 weeks	No
Secondary	Efficacy	Change from baseline to week 12 in ADAS-Cog score.	12 weeks	No

External Links

•   Sponsor's website