Effect of NeuroAD on Alzheimer Patients
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NeuroAD
Sham device
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, TMS, NeuroAd, cognitive training, ADAS-Cog
Eligibility Criteria
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
Sites / Locations
- Chungnam national university hospital, Daejeon Geriatric Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
NeuroAD
Sham NeuroAD
Arm Description
Treatment by the NeuroAD device, real treatment by synchronized TMS+cognitive training
Sham TMS+cog, has the same sound and appearance, patients come for the same number of treatments and are exposed to the same procedure.
Outcomes
Primary Outcome Measures
ADAS-Cog
Alzheimer's disease assessment scale - cognitive test
Secondary Outcome Measures
Full Information
NCT ID
NCT01825317
First Posted
April 2, 2013
Last Updated
April 17, 2014
Sponsor
Neuronix Ltd
Collaborators
company: K The Power, Chungnam National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01825317
Brief Title
Effect of NeuroAD on Alzheimer Patients
Official Title
Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuronix Ltd
Collaborators
company: K The Power, Chungnam National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, TMS, NeuroAd, cognitive training, ADAS-Cog
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NeuroAD
Arm Type
Active Comparator
Arm Description
Treatment by the NeuroAD device, real treatment by synchronized TMS+cognitive training
Arm Title
Sham NeuroAD
Arm Type
Sham Comparator
Arm Description
Sham TMS+cog, has the same sound and appearance, patients come for the same number of treatments and are exposed to the same procedure.
Intervention Type
Device
Intervention Name(s)
NeuroAD
Other Intervention Name(s)
NICE
Intervention Description
synchronized TMS+COGNITIVE TRAINING
Intervention Type
Device
Intervention Name(s)
Sham device
Other Intervention Name(s)
Control device
Intervention Description
Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.
Primary Outcome Measure Information:
Title
ADAS-Cog
Description
Alzheimer's disease assessment scale - cognitive test
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chungnam national university hospital, Daejeon Geriatric Medical Center
City
Daejeon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of NeuroAD on Alzheimer Patients
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