Alzheimer's Disease
Conditions
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
Interventions
DEVICETMS, H coil
TMS, H Coil, High/ Low Frequency
Sponsors
Brainsway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women aged 50-85. 2. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria). 3. Scored below 24 on the MMSE. 4. 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. 5. Answered in the negative to all questions in the pre-TMS treatment safety questionnaire. 6. Gave their oral and written consent to participate in the trial.
Exclusion criteria
1. An additional neurological or psychiatric disorder. 2. Severe personality disorder. 3. Uncontrolled hypertension. 4. History of epilepsy, seizure, or heat convulsion. 5. History of epilepsy or seizure in first degree relatives. 6. History of head injury or stroke. 7. History of metal implants in the head (except dental fillings). 8. History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps. 9. History of migraines in the last six months. 10. History of drug or alcohol abuse. 11. Inadequate communication with examiner. 12. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it. 13. Inability to sign a consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cognitive functioning score by ADAS-COG | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Global advancement score by CGI-C | 4 months |
| Frontal lobe functioning score by FAB | 4 months |
| Daily activity score by ADL | 4 months |
Countries
Israel
Outcome results
None listed