Effects of a NeuroAD System, for the Treatment of Alzheimer Disease

Alzheimer's Disease Clinical Trial

Official title:

Effects of a NeuroAD System, for the Treatment of Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02166827
• Other study ID #: NRX-LT1
• Status: Terminated
• Phase: N/A
• First received: June 15, 2014
• Last updated: March 30, 2017
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: March 2017
• Source: Neuronix Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the long-term efficacy of the NeuroAD system

Description:

To evaluate the long-term efficacy of the NeuroAD system in improvement of mild- to moderate Alzheimer patients' cognitive function

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Device:
• NeuroAD
Synchronized TMS and cognitive stimulation to 6 brain areas.
• Sham TMS+Cog
Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises.

Locations

Country	Name	City	State
Israel	Shaare Zedek	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Neuronix Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Adverse events (AE's), including serious adverse events (SAEs) occurring at any time during the trial and follow-up	9 Months
Primary	Efficacy	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	3 Months
Secondary	Efficacy	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	7 weeks
Secondary	Efficacy	Change from Baseline to 6 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change	6 Months
Secondary	Efficacy	Change from Baseline to 9 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change	9 Months

External Links

•   Sponsor's website