Actively Recruiting

Phase Not Applicable
Age: 50Years - 85Years
All Genders
NCT07075770

Novel Personalized Non Invasive Combined Magnetic and Electrical Stimulation of the DMN in Mild AD Patients

Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2026-01-13

60

Participants Needed

2

Research Sites

138 weeks

Total Duration

On this page

Sponsors

I

I.R.C.C.S. Fondazione Santa Lucia

Lead Sponsor

I

IRCCS Centro Neurolesi Bonino Pulejo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Alzheimer's disease (AD) is increasingly recognized as a disorder marked by early synaptic dysfunction and disrupted brain network connectivity, beyond the traditional focus on amyloid pathology. Synaptic plasticity (crucial for learning and memory) is compromised in AD and represents a promising therapeutic target. In particular, alterations in the Default Mode Network (DMN), especially in regions like the precuneus, suggest that restoring connectivity and enhancing plasticity may improve cognitive outcomes. This project proposes a novel, precision-delivered non-invasive brain stimulation protocol that combines repetitive transcranial magnetic stimulation (rTMS) and transcranial alternating current stimulation (tACS) over the DMN. The intervention will be evaluated through cognitive testing, blood-based biomarkers, MRI and TMS-EEG, alongside immersive virtual environments to assess sensorimotor and cognitive function. This approach aims to test neuromodulation strategies capable of slowing neurodegeneration and supporting early detection and rehabilitation in AD.

CONDITIONS

Official Title

Novel Personalized Non Invasive Combined Magnetic and Electrical Stimulation of the DMN in Mild AD Patients

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Alzheimer's disease according to IWG criteria
  • Mini-Mental State Examination (MMSE) score between 20 and 28
  • Presence of specific CSF biomarkers or positive Amyloid PET scan showing amyloid pathology
  • Global Clinical Dementia Rating (CDR) of 1 or less
  • Documented cognitive decline for more than six months
  • Caregiver available and living in the same household or regularly interacting with the patient
  • Patient living at home or in a nursing home without continuous nursing care
  • General health status suitable for participation in a 6-month clinical trial
  • Stable medication treatment for at least one month before screening
  • No regular use of prohibited medications
  • Signed informed consent by patient and caregiver if patient capacity is uncertain
Not Eligible

You will not qualify if you...

  • Failure to complete screening or baseline exams
  • Hospitalization or change in chronic medications within one month before or during screening
  • Presence of other primary degenerative dementias (e.g., Lewy body, frontotemporal, Huntington's, Creutzfeldt-Jakob, Down syndrome)
  • Other neurodegenerative diseases (e.g., Parkinson's, ALS)
  • Orthostatic hypotension or autonomic disorders
  • Significant cerebrovascular disease (major infarction, strategic or multiple lacunar infarcts, large white matter lesions)
  • Other central nervous system diseases (severe brain injury, tumors, subdural hematoma, space-occupying lesions)
  • Seizure disorders
  • Infectious, metabolic, or systemic diseases affecting the central nervous system (e.g., syphilis, hypothyroidism, vitamin B12 or folate deficiency, electrolyte imbalances, juvenile diabetes)
  • Current diagnosis of major depression, schizophrenia, or bipolar disorder
  • Advanced or unstable diseases interfering with study assessments or posing special risks
  • Disabilities preventing completion of study requirements (e.g., blindness, deafness, severe language difficulties)
  • Use of opioid-containing analgesics
  • Known or suspected drug or alcohol abuse (more than about 60 g alcohol per day)
  • Any condition judged by the investigator to make the patient unsuitable for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

IRCCS Santa Lucia Foundation

Rome, Italy, Italy, 00179

Actively Recruiting

2

I.R.C.C.S. Centro Neurolesi Bonino Pulejo

Messina, Sicily, Italy, 98124

Not Yet Recruiting

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Research Team

G

Giacomo Koch, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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