Predicting the effectiveness of rTMS in Alzheimer's patients
Prediction of Cognitive, Neurotrophic, Anti-Inflammatory, and Antioxidant Effectiveness of rTMS Application in Alzheimer's Patients
This study is testing whether a new brain treatment called rTMS can help people with Alzheimer's by looking at their brain activity and other health markers before and after the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Istanbul Medipol University Hospital Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT05977088 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential of repetitive Transcranial Magnetic Stimulation (rTMS) as a non-pharmacological treatment for Alzheimer's disease. It aims to predict the benefit rate of rTMS by evaluating various parameters before treatment, including EEG data and blood samples to assess neuroprotective, anti-inflammatory, and antioxidant effects. The study will involve 20 participants who will undergo rTMS treatment over five days, with EEG recordings taken before and after the treatment to analyze changes in brain activity. The findings could provide insights into the effectiveness of rTMS in modifying the disease process in Alzheimer's patients.
Who should consider this trial
Good fit: Ideal candidates are individuals over 55 years old diagnosed with clinical Alzheimer's Disease and a Clinical Dementia Rating Scale score of 1-2.
Not a fit: Patients with severe neurological conditions, head trauma, or those currently receiving investigational treatments for Alzheimer's may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new non-drug treatment option for patients with Alzheimer's disease.
How similar studies have performed: While the use of rTMS in neurological conditions is being explored, this specific application in Alzheimer's disease is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have been diagnosed with clinical Alzheimer's Disease in accordance with the NINCDS-ADRDA diagnostic criteria * \>55 years old * Clinical Dementia Rating Scale (CDR) score in the 1-2 range * Not having any other disease that affects their cognitive functions * Volunteer to participate in the study Exclusion Criteria: * Participant or relative does not give consent * The patient's inability to participate in the entire study procedure (eg living in another city) * The patient's history of head trauma with alcohol/substance abuse * Presence of severe stroke and other neurological sequelae disease in the participant * Presence of a metal implant on the head or having a pacemaker and contraindications for other TMS applications During the study or 1 month before, having/been receiving/receiving an investigational drug targeting Alzheimer's disease or neuromodulation treatment such as tDCS and TMS, other than standard treatment for AD symptom control such as acetylcholine esterase and memantine, with the potential to affect the study
Where this trial is running
Istanbul
- Medipol University Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Lutfu Hanoglu, Prof. DR. MD — Medipol University
- Study coordinator: Lutfu Hanoglu, Prof. DR. MD
- Email: lhanoglu@kure.com.tr
- Phone: +90 444 8 544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.