Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- Brainsway
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- cognitive functioning score by ADAS-COG
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.
Detailed Description
Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months. Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2 Ages: 50-85 Genders: both
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women aged 50-
- •Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
- •Scored below 24 on the MMSE.
- •Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response.
- •Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
- •Gave their oral and written consent to participate in the trial.
- •Exclusion criteria:
- •An additional neurological or psychiatric disorder.
- •Severe personality disorder.
- •Uncontrolled hypertension.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
cognitive functioning score by ADAS-COG
Time Frame: 4 months
Secondary Outcomes
- Global advancement score by CGI-C(4 months)
- Frontal lobe functioning score by FAB(4 months)
- Daily activity score by ADL(4 months)