Study Stopped
Administrative decision
Effects of a NeuroAD System, for the Treatment of Alzheimer Disease
1 other identifier
interventional
1
1 country
1
Brief Summary
To evaluate the long-term efficacy of the NeuroAD system
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedMarch 31, 2017
March 1, 2017
1 year
June 15, 2014
March 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Efficacy
7 weeks
Efficacy
6 Months
Efficacy
9 Months
Other Outcomes (1)
Safety
9 Months
Study Arms (2)
NeuroAD
ACTIVE COMPARATORNeuroAd Treatment, synchronized TMS and cognitive training stimulation
Sham TMS+Cog
SHAM COMPARATORSham 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.
Interventions
Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises.
Eligibility Criteria
You may qualify if:
- Male or female age 60-90 years
- Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria
- MMSE score 18 to 26
- Physical clearance for study participation as evaluated by the clinician
- 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)
- Informed consent by the patient or by legally authorized person if appointed
You may not qualify if:
- CDR 0, 0.5 or 3
- Severe agitation
- Mental retardation
- History of Epileptic Seizures or Epilepsy
- Contraindication for performing MRI scanning
- Contraindication for receiving TMS treatment according to a TMS questionnaire
- 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
- Cardiac pacemakers
- Implanted medication pumps
- Intracardiac lines
- Significant heart disease
- Currently taking medication that lower the seizure threshold
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuronix Ltdlead
Study Sites (1)
Shaare Zedek
Jerusalem, 9103102, Israel
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2014
First Posted
June 18, 2014
Study Start
November 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
March 31, 2017
Record last verified: 2017-03