Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- Neuronix Ltd
- Enrollment
- 131
- Locations
- 10
- Primary Endpoint
- Efficacy
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Detailed Description
The NeuroAD system is a combined system of Transcranial Magnetic Stimulation and cognitive training and is a non-invasive therapeutic system for the improvement of Alzheimer patients' cognitive function. A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment or sham (placebo) Patient will attend the clinic 5 times a week for 6 weeks, approximately an hour every day for treatment/sham. The patient will be required to return to the clinic for follow-up. Up to 150 patients will be enrolled in up to 10 clinical sites in the US and Israel.
Investigators
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
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Efficacy
Time Frame: 7 weeks
Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
Secondary Outcomes
- Efficacy(12 weeks)