NCT04263194

Network-based rTMS in Alzheimer's Disease

Status unknown NA Last updated 13 March 2023

What this trial tests

NA trial testing rTMS in Alzheimer Disease, Late Onset in 60 participants. Status unknown.

Timeline

21 March 2019

Primary endpoint
21 September 2023

21 March 2024

Quick facts

Lead sponsor	IRCCS Centro San Giovanni di Dio Fatebenefratelli
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	60
Start date	21 March 2019
Primary completion	21 September 2023
Estimated completion	21 March 2024
Sites	1 location across Italy

Drugs / interventions tested

• rTMS
• Sham rTMS

Conditions studied

• Alzheimer Disease, Late Onset — all drugs for Alzheimer Disease, Late Onset →
• Alzheimer Disease — all drugs for Alzheimer Disease →
• Cognitive Deterioration — all drugs for Cognitive Deterioration →

Sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Who can join

Adults 55 to 85, any sex, with Alzheimer Disease, Late Onset or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Severe alterations of brain networks connectivity have been described in Alzheimer's disease (AD). Repetitive Transcranial Magnetic Stimulation (rTMS) has gained evidence as an effective tool to modulate brain networks connectivity, leading to a recovery or reorganization of both local and remote brain regions functionally connected to the stimulated area. The investogators propose an innovative tailored network-based rTMS treatment to ameliorate cognitive symptoms in mild AD, through the boosting of connectivity within brain networks affected by AD pathophysiology. The combination of the proposed intervention with an integrated multi-modal imaging approach will allow to evaluate the neural mechanisms underlying the clinical response to the treatment and to define quantitative markers of clinical impact on AD. If successful, the present proposal would immediately impact on patient's quality of life, with important implications for the time and costs of delivery of rehabilitative services.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modulation of Brain Hyperexcitability: Potential New Therapeutic Approaches in Alzheimer's Disease.
   Toniolo S, Sen A, Husain M. · · 2020 · cited 74× · PMID 33297460 · DOI 10.3390/ijms21239318
2. Therapy for Alzheimer's disease: Missing targets and functional markers?
   Stoiljkovic M, Horvath TL, Hajós M. · · 2021 · cited 52× · PMID 33711510 · DOI 10.1016/j.arr.2021.101318
3. Functional Imaging to Guide Network-Based TMS Treatments: Toward a Tailored Medicine Approach in Alzheimer's Disease.
   Bagattini C, Brignani D, Bonnì S, Quattrini G, et al · · 2021 · cited 16× · PMID 34290585 · DOI 10.3389/fnins.2021.687493
4. Repetitive Transcranial Magnetic Stimulation in the Treatment of Alzheimer's Disease and Other Dementias.
   Aloizou AM, Pateraki G, Anargyros K, Siokas V, et al · · 2021 · cited 8× · PMID 34442086 · DOI 10.3390/healthcare9080949