CompletedNot Applicable

Non-invasive Stimulation of Brain Networks and Cognition in Alzheimer's Disease and Frontotemporal Dementia

Italy45 participantsStarted 2015-06-08

Plain-language summary

This pilot study aims to test clinical and connectivity changes following non-invasive stimulation of disease-specific networks in Alzheimer's disease (AD) and behavioral variant frontotemporal dementia (bvFTD). Brain network stimulation will be carried out with transcranial direct current stimulation (tDCS). Target networks will be the default mode network (DMN) and salience network (SN). Twenty AD and 20 bvFTD patients will be recruited and assessed with a comprehensive clinical, behavioral and cognitive battery, and 3 Tesla MRI scan (including resting-state functional MRI, arterial spin labeling, diffusion tensor imaging, structural MRI) at three time-points: baseline, after tDCS, and after 6 months. Patients will be randomized to 2 arms: anodal stimulation of the disease-specific network (DMN in AD, SN in bvFTD) or cathodal stimulation of the anti-correlated network (SN in AD, DMN in bvFTD). The intervention will consist of 10 tDCS sessions over two weeks. Cerebrospinal fluid (CSF) samples will be collected at baseline for biomarker's assessment; blood samples will be collected at each time-point to assess changes in peripheral inflammatory markers. Blood and CSF collection will be optional. A sample of 20 elderly controls will be included for baseline comparisons.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of AD or bvFTD according to current clinical criteria (Albert et al., 2011; Rascovsky et al., 2011) * Ability to provide written informed consent * Availability of a collateral source Exclusion Criteria: * Moderate/severe dementia * Presence of any medical or psychiatric illness that could interfere in completing assessments Exclusion Criteria for MRI and tDCS: * metal implants, pace-makers, prosthetic heart valves * claustrophobia * history of epilepsy * pregnancy Exclusion Criteria for controls: * Current or past history of clinical, neurological, or psychiatric conditions that could interfere with the assessment (e.g., transient ischemic attack, ictus, head trauma, epilepsy, multiple sclerosis, neuropathy, mood disorders, substance abuse)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Clinical Disease Severity (CDR)

Timeframe: Baseline, post tDCS (week 3)

Change in Behavioral Symptom Severity (NPI)

Timeframe: Baseline, post tDCS (week 3)

Change in Behavioral Symptom Severity (FBI)

Timeframe: Baseline, post tDCS (week 3)

Change in Functional Connectivity

Timeframe: Baseline, post tDCS (week 3)

Change in Cerebral Blood Flow

Timeframe: Baseline, post tDCS (week 3)

Trial details

NCT IDNCT03422250

SponsorIRCCS Centro San Giovanni di Dio Fatebenefratelli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-03

Results submitted2021-03-03

View on ClinicalTrials.gov More Alzheimer's Disease trials

Plain-language summary

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Clinical Disease Severity (CDR)

Timeframe: Baseline, post tDCS (week 3)

Change in Behavioral Symptom Severity (NPI)

Timeframe: Baseline, post tDCS (week 3)

Change in Behavioral Symptom Severity (FBI)

Timeframe: Baseline, post tDCS (week 3)

Change in Functional Connectivity

Timeframe: Baseline, post tDCS (week 3)

Change in Cerebral Blood Flow

Timeframe: Baseline, post tDCS (week 3)