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

NCT ID: NCT02166827

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-11-30

Brief Summary

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To evaluate the long-term efficacy of the NeuroAD system

Detailed Description

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

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NeuroAD

NeuroAd Treatment, synchronized TMS and cognitive training stimulation

Group Type ACTIVE_COMPARATOR

NeuroAD

Intervention Type DEVICE

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. Patients come for the same number of sessions, delivers no real stimulation or cognitive training.

Group Type SHAM_COMPARATOR

Sham TMS+Cog

Intervention Type DEVICE

Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises.

Interventions

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NeuroAD

Synchronized TMS and cognitive stimulation to 6 brain areas.

Intervention Type DEVICE

Sham TMS+Cog

Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises.

Intervention Type DEVICE

Other Intervention Names

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NICE

Eligibility Criteria

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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

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neuronix Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shaare Zedek

Jerusalem, , Israel

Site Status

Countries

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Israel

Related Links

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Other Identifiers

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NRX-LT1

Identifier Type: -

Identifier Source: org_study_id

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