Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | Verum rTMS |
|
| Sham | Sham Comparator | sham rTMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive transcranial magnetic stimulation | Device | 20 Hz repetitive transcranial magnetic stimulation targeted at the precuneus |
|
| Measure | Description | Time Frame |
|---|---|---|
| CDR - Sum of Boxes | Clinical dementia rating - sum of boxes | from enrollment to 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetoencephalography (MEG): Spectral analysis | Power spectral density (µV²/Hz) computed for different frequency bands . | from baseline to week 24 (post-treatment) |
| Cerebrospinal fluid (CSF) biomarkers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Willem De Haan, PhD | Contact | 020-444 8548 | w.dehaan@amsterdamumc.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36281767 | Background | 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. |
Not provided
Not provided
The individual participant data will be made available upon reasonable request to the corresponding author in consultation with the data protection officer
Not provided
Data will be shared after the study completion indefinitely
Upon reasonable request
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sham repetitive transcranial magnetic stimulation | Device | 20 Hz sham repetitive transcranial magnetic stimulation targeted at the precuneus |
|
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
| from baseline to week 24 (post-treatment) |
| Neuropsychological evaluation: Trail Making Test | Assesses visual attention, processing speed, and task switching. Unit: Seconds (completion time) | from baseline to week 24 (post-treatment) |
| 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). | baseline to 3 month follow-up |
| Mini mental state examination (MMSE) | The mini-mental state examination (MMSE) test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Higher is better. | baseline to 3-month follow up. |
| Neuropsychiatric Inventory Questionnaire (NPI-Q) | The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a brief, informant-based tool that assesses 12 neuropsychiatric symptoms in dementia, with total severity scores ranging from 0 to 36 and distress scores from 0 to 60. | baseline to 3 month follow up |
| Quick Inventory of Depressive Symptomatology (QIDS) | The Quick Inventory of Depressive Symptomatology (QIDS) is a clinician-rated tool that measures the severity of depressive symptoms, with total scores ranging from 0 (no depression) to 27 (severe depression). | baseline to 3-month follow up |
| Magnetoencephalography (MEG): Corrected Amplitude Envelope Correlation (AEC-c) | Correlation of the amplitude envelopes of band-pass filtered signals, corrected for signal leakage. | From baseline to week 24 (post-treatment) |
| Magnetoencephalography (MEG): Phase Lag Index (PLI) | A measure of phase synchronization that is robust to volume conduction. | baseline to week 24 (post-treatment) |
| Magnetoencephalography (MEG): Joint Permutation Entropy (JPE) | A nonlinear measure of signal complexity and diversity in joint time series. | baseline to week 24 (post-treatment) |
| Neuropsychological evaluation: Verbal Fluency Test | Measures verbal production and executive functioning. Phonemic fluency (letters D, A, T) Unit: Number of words per 1 minute Semantic fluency (animals) Unit: Number of words per 1 minute | baseline to week 24 (post-treatment) |
| Neuropsychological evaluation: Visual Association Test (VAT) | Detects signs of anterograde amnesia through object-pair associations. Unit: Number of correct associations (maximum score: 12) | baseline to week 24 (post-treatment) |
| Neuropsychological evaluation: Stroop Color and Word Test | Evaluates cognitive flexibility, inhibition, and processing speed. Unit: Seconds (per condition), Errors (count) | baseline to week 24 (post-treament) |
| Neuropsychological evaluation: WAIS-III Digit Span (Forward and Backward) | Assesses attention and verbal working memory. Unit: Span length (maximum correctly repeated digit sequences) | baseline to week 24 (post-treatment) |
| Neuropsychological evaluation: Rey Auditory Verbal Learning Test (RAVLT) | Evaluates verbal learning and declarative memory. Immediate recall (Trials I-V) Unit: Total number of words recalled Delayed recall Unit: Number of words recalled Recognition Unit: Number of correct recognitions | baseling to week 24 (post-treatment) |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |