Transcranial Magnetic Stimulation to Slow Down Cognitive Decline in Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorWillem de Haan
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
repetitive transcranial magnetic stimulation
Device20 Hz repetitive transcranial magnetic stimulation targeted at the precuneus
sham repetitive transcranial magnetic stimulation
Device20 Hz sham repetitive transcranial magnetic stimulation targeted at the precuneus
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: VerumExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
CDR - Sum of Boxes
Clinical dementia rating - sum of boxes
Time frame
from enrollment to 3 month follow-upSecondary outcomes
1
Magnetoencephalography (MEG): Spectral analysis
Power spectral density (µV²/Hz) computed for different frequency bands .
Time frame
from baseline to week 24 (post-treatment)2
Cerebrospinal fluid (CSF) biomarkers
Cerebrospinal fluid (CSF) biomarkers are typically reported in picograms per milliliter (pg/mL). This applies to: Amyloid-beta (Aβ₁-₄₂): pg/mL Total tau (t-tau): pg/mL Phosphorylated tau (p-tau, e.g., p-tau181): pg/mL
Time frame
from baseline to week 24 (post-treatment)3
Neuropsychological evaluation: Trail Making Test
Assesses visual attention, processing speed, and task switching. Unit: Seconds (completion time)
Time frame
from baseline to week 24 (post-treatment)4
Amsterdam instrumental activities of daily living questionnaire (AmsterdamiADL);
The Amsterdam Instrumental Activities of Daily Living (A-IADL) Questionnaire is a validated tool that assesses cognitive functioning through everyday tasks, with scores ranging from approximately 20 (severe impairment) to 70 (no impairment).
Time frame
baseline to 3 month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Willem de Haan
Lead sponsor
Amsterdam UMC, location VUmc
Sponsor institution
Source ClinicalTrials.gov