Transcranial Magnetic Stimulation to Slow Down Cognitive Decline in Alzheimer's Disease

Last updated: June 23, 2025
Sponsor: Willem de Haan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Mild Cognitive Impairment

Memory Problems

Treatment

sham repetitive transcranial magnetic stimulation

repetitive transcranial magnetic stimulation

Clinical Study ID

NCT07036328
2024.0870
  • Ages 50-85
  • All Genders

Study 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

Inclusion Criteria:

  • Biomarker-supported Alzheimer's disease (abnormal CSF p-tau/Aβ42 ratio of > 0.023 oramyloid 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 26.

  • Presence of a caregiver.

Exclusion

Exclusion Criteria:

  • Medical history of neurodegenerative diseases other than AD, stroke, or epilepsy.

  • Severe psychiatric dysregulation, hampering successful study participation andleading to possible cognitive impairment. Eligibility for participation will bebased on clinical evaluation by an expert neurologist and/or psychiatrist.

  • Extensive cerebrovascular damage on MRI classified as Fazekas level 2 or 3. Patientswith 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 cochlearimplants.

  • Cholinesterase inhibitors with unstable dosage in the last 2 months.

  • Extreme claustrophobia or metallic objects in or on the body, preventing MRI and MEGexamination.

  • Previous rTMS treatment (for blinding reasons).

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: sham repetitive transcranial magnetic stimulation
Phase:
Study Start date:
April 07, 2025
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

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