Status:
COMPLETED
Repetitive TMS of the Default Mode Network in AD
Lead Sponsor:
I.R.C.C.S. Fondazione Santa Lucia
Conditions:
Alzheimer Disease
Eligibility:
All Genders
30-85 years
Phase:
NA
Brief Summary
Alzheimer's disease is a global health challenge. Efforts aim at developing an effective treatment able to meet the needs of patients and their families. Thus, the primary aim of this project is to in...
Detailed Description
Background: Alzheimer's disease (AD) is a neurodegenerative disorder characterized by severe disruption of large-scale brain networks connectivity. AD pathophysiology has been mainly associated with a...
Eligibility Criteria
Inclusion
- The patient and the responsible caregiver have signed the Informed Consent Form.
- The patient has probable AD, diagnosed according to NINCDS-ADRDA criteria.
- The patient is a man or woman, aged ≤ 85 years.
- The patient has a CDR total score of 0.5 or 1 (mild) and MMSE score of 18-26 (inclusive) at Screening.
- Has at least one identified adult caregiver
- The patient has been treated with acetylcholinesterase inhibitor (AChEI), i.e., donepezil, galantamine, or rivastigmine, at the time of Screening
- For at least 3 months
- The current dosage regimen must have remained stable for ≥ 8 weeks
- It must be planned that the dosage regimen will remain stable throughout participation in the study
- The patient is able to comply with the study procedures in the view of the investigator.
Exclusion
- Significant neurodegenerative disorder of the central nervous system other than Alzheimer's disease
- Significant intracranial focal or vascular pathology seen on brain MRI scan
- History of seizure (with the exception of febrile seizures in childhood)
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM IV-TR) criteria met for any of the following within specified period:
- Major depressive disorder (current)
- Schizophrenia (lifetime)
- Other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders (within the past 5 years)
- Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MR imaging.
- Treatment currently or within 3 months before Baseline with any of the following medications:
- Typical and atypical antipsychotics (i.e. Clozapine, Olanzapine)
- Antiepileptics drugs (i.e. Carbamazepine, Primidone, Pregabalin, Gabapentin)
- Memantine
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03778151
Start Date
February 1 2018
End Date
October 1 2020
Last Update
February 8 2021
Active Locations (2)
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1
Giacomo Koch
Rome, Italy, 00179
2
Santa Lucia Foundation
Rome, Italy, 00179