Transcranial Magnetic Stimulation to Slow Down Cognitive Decline in Alzheimer's Disease
TMSLA
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable alzheimer-disease
Started Apr 2025
Typical duration for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2025
CompletedFirst Submitted
Initial submission to the registry
April 24, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
June 25, 2025
May 1, 2025
2.7 years
April 24, 2025
June 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
CDR - Sum of Boxes
Clinical dementia rating - sum of boxes
from enrollment to 3 month follow-up
Secondary Outcomes (15)
Magnetoencephalography (MEG): Spectral analysis
from baseline to week 24 (post-treatment)
Cerebrospinal fluid (CSF) biomarkers
from baseline to week 24 (post-treatment)
Neuropsychological evaluation: Trail Making Test
from baseline to week 24 (post-treatment)
Amsterdam instrumental activities of daily living questionnaire (AmsterdamiADL);
baseline to 3 month follow-up
Mini mental state examination (MMSE)
baseline to 3-month follow up.
- +10 more secondary outcomes
Study Arms (2)
Verum
EXPERIMENTALVerum rTMS
Sham
SHAM COMPARATORsham rTMS
Interventions
20 Hz repetitive transcranial magnetic stimulation targeted at the precuneus
20 Hz sham repetitive transcranial magnetic stimulation targeted at the precuneus
Eligibility Criteria
You may qualify if:
- 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 26.
- Presence of a caregiver.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Willem de Haanlead
Study Sites (1)
Amsterdam UMC
Amsterdam, Netherlands
Related Publications (1)
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: 36281767BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 24, 2025
First Posted
June 25, 2025
Study Start
April 7, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
June 25, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be shared after the study completion indefinitely
- Access Criteria
- Upon reasonable request
The individual participant data will be made available upon reasonable request to the corresponding author in consultation with the data protection officer