- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01825317
Effect of NeuroAD on Alzheimer Patients
April 17, 2014 updated by: Neuronix Ltd
Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Synchronized TMS and cognitive training for the treatment of mild to moderate Alzheimer's patients. Treatment is delivered 5 days a week, for 6 weeks, visit is about an hour long.
Evaluation is by neuropsychological evaluation at 6 weeks.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Daejeon, Korea, Republic of
- Chungnam national university hospital, Daejeon Geriatric Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Physically acceptable for the study as confirmed by medical history and exam.
- 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 or corrected to normal ability to see and to hear.
- Korean as primary language
- 8th grade education minimum
Exclusion Criteria:
- CDR 0 or 3
- Severe agitation;
- Mental retardation;
- Patient lacking capacity to consent to study participation
- Unstable medical condition;
- Use of benzodiazepines or barbiturates during the study and preceding two weeks;
- Pharmacological immunosuppression;
- Participation in a clinical trial with any investigational agent within two weeks 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 personal history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, or multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness.
- 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 treated with cholinesterase inhibitors, or memantine or Ginko-biloba will be allowed to participate, if the treatment has started at least 6 months previous to recruitment. The patients should keep their dose of medication during the whole trial as prior to study begin.
- Patients with metal in the head, except the mouth (i.e. cochlear implants, implanted brain stimulators, aneurysm clips)
- Patients with increased intracranial pressure
- Cardiac pacemakers
- Implanted neurostimulators
- Implanted medication pumps
- Intracardiac lines
- Significant heart disease
- Currently taking medication that lower the seizure threshold
- Significant sleep deprivation and alcoholism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: NeuroAD
Treatment by the NeuroAD device, real treatment by synchronized TMS+cognitive training
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synchronized TMS+COGNITIVE TRAINING
Other Names:
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Sham Comparator: Sham NeuroAD
Sham TMS+cog, has the same sound and appearance, patients come for the same number of treatments and are exposed to the same procedure.
|
Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADAS-Cog
Time Frame: 6 weeks
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Alzheimer's disease assessment scale - cognitive test
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6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
April 2, 2013
First Submitted That Met QC Criteria
April 4, 2013
First Posted (Estimate)
April 5, 2013
Study Record Updates
Last Update Posted (Estimate)
April 21, 2014
Last Update Submitted That Met QC Criteria
April 17, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRX-KOR1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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