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Recruiting NCT07036328

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

No phase Interventional Alzheimer Disease Alzheimer Disease, Early Onset

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: repetitive transcranial magnetic stimulation, sham repetitive transcranial magnetic stimulation.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Alzheimer Disease, Early Onset. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Transcranial Magnetic Stimulation (TMS) to Slow Down Cognitive Decline in Alzheimer's Disease (AD): TMSLA - a Monocentric Randomized Controlled Trial.

Overview

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.

Interventions

  • Device repetitive transcranial magnetic stimulation
    20 Hz repetitive transcranial magnetic stimulation targeted at the precuneus
  • Device sham repetitive transcranial magnetic stimulation
    20 Hz sham repetitive transcranial magnetic stimulation targeted at the precuneus

Primary outcome measures

  • CDR - Sum of Boxes [Time frame: from enrollment to 3 month follow-up]
Secondary outcome measures (12)
  • Magnetoencephalography (MEG): Spectral analysis [Time frame: from baseline to week 24 (post-treatment)]
  • Cerebrospinal fluid (CSF) biomarkers [Time frame: from baseline to week 24 (post-treatment)]
  • Neuropsychological evaluation: Trail Making Test [Time frame: from baseline to week 24 (post-treatment)]
  • Amsterdam instrumental activities of daily living questionnaire (AmsterdamiADL); [Time frame: baseline to 3 month follow-up]
  • Mini mental state examination (MMSE) [Time frame: baseline to 3-month follow up.]
  • Neuropsychiatric Inventory Questionnaire (NPI-Q) [Time frame: baseline to 3 month follow up]
  • Quick Inventory of Depressive Symptomatology (QIDS) [Time frame: baseline to 3-month follow up]
  • Magnetoencephalography (MEG): Corrected Amplitude Envelope Correlation (AEC-c) [Time frame: From baseline to week 24 (post-treatment)]
  • Magnetoencephalography (MEG): Phase Lag Index (PLI) [Time frame: baseline to week 24 (post-treatment)]
  • Magnetoencephalography (MEG): Joint Permutation Entropy (JPE) [Time frame: baseline to week 24 (post-treatment)]
  • Neuropsychological evaluation: Verbal Fluency Test [Time frame: baseline to week 24 (post-treatment)]
  • Neuropsychological evaluation: Visual Association Test (VAT) [Time frame: baseline to week 24 (post-treatment)]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Amsterdam UMC — Amsterdam

Publications

  • Koch G, Casula EP, Bonni S, Borghi I, Assogna M, Minei M, Pellicciari MC, Motta C, D'Acunto A, Porrazzini F, Maiella M, Ferrari C, Caltagirone C, Santarnecchi E, Bozzali M, Martorana A. Precuneus magnetic stimulation for Alzheimer's disease: a randomized, sham-controlled trial. Brain. 2022 Nov 21;145(11):3776-3786. doi: 10.1093/brain/awac285. PMID 36281767

Identifiers

NCT: NCT07036328 · 2024.0870

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗