- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01168245
TMS Stimulation and Cognitive Training in Alzheimer Patients
Effects of a Combined TMS Stimulation and Cognitive Training in Alzheimer Patients: a Single-center, Randomized, Double-blind, Placebo-controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current available pharmaceutical treatment for Alzheimer Disease (AD) is only partially and temporary effective. Therefore, new approaches are needed. rTMS is a non-invasive technique which generates a small electric current that induces a modulation in cortical excitability. In addition, cognitive training was suggested to improve cognitive functions in Alzheimer patients.
In this study we intend to treat mild to moderate AD patients with rTMS interlaced with cognitive training (rTMS- COG).
Patients with probable AD will be treated with rTMS-COG daily for 6 weeks followed by maintenance sessions for additional 3 months.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Beer Yaakov, Israel, 70300
- Assaf-Harofeh Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female age 55-85 years
- Patients diagnosed with early or moderate stage of Alzheimer's disease, according to the DSM-IV criteria.
- MMSE score 18 to 24
- Global Dementia rating 1 or 2
- Physically acceptable for the study as confirmed by medical history and exam, clinical laboratory results and EKG
- Spouse, family member or professional caregiver agree and capable of taking care and responsibility for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
- Written informed consent by both patient and legally responsible caregiver.
- Able to undergo MRI scan and EEG recordings prior to the onset of the study.
- Agreement to participate in up to 9 months the study.
- Right handed
- Hebrew or Russian as mother tongue and/or ability to read and understand the inform consent form (ICF), and the Patient Information document in Hebrew or Russian.
Exclusion Criteria:
- Severe agitation;
- Mental retardation;
- Unstable medical condition;
- Use of benzodiazepines or other hypnotics 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;
- Alcoholism;
- History of Epileptic Seizures or Epilepsy;
- Contraindication for performing MRI scanning;
- Contraindication for receiving TMS treatment according to a TMS questionnaire;
- Clinically significant abnormal laboratory findings which have not been approved by the Principle Investigator;
- Patients treated with cholinesterase inhibitors, or memantine or ginko-biloba will be allowed to participate, if the treatment has started at least 2 months previous to recruited.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: NICE-System NeuroAD
Treatment Group
|
TMS combined with cognitive training
|
SHAM_COMPARATOR: Sham-TMS
Control Group
|
sham TMS and sham cognitive training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A significant improvement and/or improvement of at least 2 points on ADAS-COG of the Treatment Group in comparison with the Placebo Group after 6 weeks of treatment.
Time Frame: pre-treatment, 6, and 18 weeks
|
pre-treatment, 6, and 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety profile: rate of device and/or procedure related adverse events.
Time Frame: weekly
|
weekly
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Rabey, Prof., Assaf-Harofeh Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRX-NICE-PLA02
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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