Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- Tel-Aviv Sourasky Medical Center
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- ADAS-COG
- Last Updated
- 14 years ago
Overview
Brief Summary
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex 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, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17). Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm. Ages: 50-80 Genders: both
Investigators
Michal Roll PhD,MBA
Dr. Alissa Ash
Tel-Aviv Sourasky Medical Center
Eligibility Criteria
Inclusion Criteria
- •Written informed consent will be obtained
- •diagnostic evidence of probable AD consistent with DSM IV
- •stable treatment with Acetylcholine-Esterase Inhibitors or/and Memantine for 5 weeks prior to screening
- •stable dose treatment with other drugs
- •MMSE \<25
Exclusion Criteria
- •Patients with neurological or psychiatric disorders that affect cognition but are distinguishable from AD
- •Patients who are unwilling or unable to fulfill the requirements of the study
- •Severe personality disorder
- •Malignant or untreated Hypertension
- •History of Epilepsy
- •History of Head trauma
- •Metal implant in head, cardiac pacemaker, medical pump
- •Drug or alcohol addiction
- •Involvement in any other clinical trial during the preceding 3 month
- •Patient who are unwilling or unable to give Informed Consent
Outcomes
Primary Outcomes
ADAS-COG
Time Frame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)
Secondary Outcomes
- CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.(Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17))