Effect of NeuroAD on the Cognitive Function of Alzheimer Patients
Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
1 other identifier
interventional
131
2 countries
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2013
CompletedFirst Posted
Study publicly available on registry
April 5, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 31, 2016
October 1, 2015
2.3 years
March 24, 2013
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
7 weeks
Secondary Outcomes (2)
Efficacy
7 weeks
Efficacy
12 weeks
Other Outcomes (1)
Safety
12 weeks
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
Synchronized TMS and cognitive stimulation to 6 brain areas.
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
- ADAS-Cog above 17
- Physical clearance for study participation as evaluated by the clinician.
- 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)
- Agreement to participate in approximately 14 weeks during the study.
- Normal to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid).
- Fluent in English or Hebrew
- Minimum of 8th grade education
- 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.
You may not qualify if:
- CDR 0, 0.5 or 3
- Severe agitation
- Mental retardation
- Patient lacking capacity to consent to study participation
- Unstable medical condition
- Use of benzodiazepines or barbiturates 2 weeks prior to screening
- Pharmacological immunosuppression
- Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment
- History of Epileptic Seizures or Epilepsy
- Contraindication for performing MRI scanning
- Contraindication for receiving TMS treatment according to a TMS questionnaire
- Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
- 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
- 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
- Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators, aneurysm clips) with the exception of metal implants in mouth
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuronix Ltdlead
Study Sites (10)
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
ATP Clinical Research, Inc.
Costa Mesa, California, 92626, United States
Miami Jewish Health Systems
Miami, Florida, 33137, United States
Roskamp Institute Clinic
Sarasota, Florida, 34243, United States
Palm Beach Neurology and Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Cleveland Clinic Lou Ruvo Brain Center
Las Vegas, Nevada, 89106, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Cleveland Clinic Center for Brain Health Lakewood Hospital
Cleveland, Ohio, 44107, United States
Assaf Harofe Medical Center
Beer Yaakov, Israel
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charlie Bernick, MD
Lou Ruvo Brain Center
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
March 24, 2013
First Posted
April 5, 2013
Study Start
October 1, 2013
Primary Completion
January 1, 2016
Study Completion
March 1, 2016
Last Updated
March 31, 2016
Record last verified: 2015-10