NCT07036328 Transcranial Magnetic Stimulation to Slow Down Cognitive Decline in Alzheimer's Disease
| NCT ID | NCT07036328 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Willem de Haan |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 55 participants in total. It began in 2025-04-07 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
New amyloid-targeting drugs for Alzheimer's disease (AD) offer minimal or unclear efficacy and often cause adverse events, highlighting the need for new therapies. In recent years, repetitive transcranial magnetic stimulation (rTMS) has shown increasing success. A recent randomized, double-blind, sham-controlled, phase 2 demonstrated promising results from a 24-week rTMS treatment protocol targeting the precuneus. This brain region is considered a main hub of the human brain connectome and a prominent area of AD pathology. The results showed stable cognitive performance and increased brain activity in the treatment group, whereas the sham group worsened. A replication study is planned to further investigate the working mechanism of precuneus-rTMS in AD and to improve understanding of its therapeutic potential.
Eligibility Criteria
Inclusion Criteria: * Biomarker-supported Alzheimer's disease (abnormal CSF p-tau/Aβ42 ratio of \> 0.023 or amyloid PET positive). * Between 50 and 85 years old. * Clinical Dementia Rating (CDR) score of 0.5 or 1. * Mini-Mental State Examination (MMSE) score between 18 and 27. * Presence of a caregiver. Exclusion Criteria: * Medical history of neurodegenerative diseases other than AD, stroke, or epilepsy. * Severe psychiatric dysregulation, hampering successful study participation and leading to possible cognitive impairment. Eligibility for participation will be based on clinical evaluation by an expert neurologist and/or psychiatrist. * Extensive cerebrovascular damage on MRI classified as Fazekas level 2 or 3. Patients with abnormalities classified as Fazekas level 3 are excluded. For Fazekas level 2, patient's eligibility for participation will be evaluated by an expert neurologist. * Presence of metal in the head or cranial/thoracic implants, including cochlear implants. * Cholinesterase inhibitors with unstable dosage in the last 2 months. * Extreme claustrophobia or metallic objects in or on the body, preventing MRI and MEG examination. * Previous rTMS treatment (for blinding reasons).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07036328 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07036328 currently recruiting?
Yes, NCT07036328 is actively recruiting participants. Contact the research team at w.dehaan@amsterdamumc.nl for enrollment information.
Where is the NCT07036328 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT07036328 clinical trial?
NCT07036328 is sponsored by Willem de Haan. The trial plans to enroll 55 participants.
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