NCT05454540Completed
Repetitive TMS of the Posterior DMN in AD
A Randomized Double-blinded Sham-controlled Trial of Precuneus RTMS in Mild to Moderate Alzheimer's Disease Patients.
Source: ClinicalTrials.gov · Last updated 18 Oct 2024
Brief summary (registry, in English)
The primary aim of this project is to investigate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognition in patients with mild to moderate Alzheimer's disease. rTMS is considered a safe, well tolerated and relatively cheap treatment. The appealing idea of the intervention is to improve memory by directly modulating the activity of precuneus, key area linked to memory impairment. Patients will be treated with rTMS in two phases: a 2-week intensive phase followed by a maintenance phase for a total of 52 weeks. This project aims to provide a valid treatment to slow the worsening of symptoms and improve quality of life for those with Alzheimer's and their caregivers.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 16 Jun 2022
- Start date
- 1 Oct 2018
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Diseases
- Alzheimer disease
- NCT number
- NCT05454540
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 1 Oct 2018 to the primary completion date, 30 Nov 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Significant neurodegenerative disorder of the central nervous system other than Alzheimer's disease
- 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)
Other
- Significant intracranial focal or vascular pathology seen on brain MRI scan
Who the study is looking for
- 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 to moderate) 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.
Age in the registry: 30 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Santa Lucia Foundation Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Giacomo Koch Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.