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We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.
This study aims to enroll 40 patients with mild and moderate Alzheimer's disease with apathy symptoms that will be randomized to receive rTMS or sham procedure. Subjects will be randomized in two arms (rTMS or sham procedure) in 1:1 proportion.
Eligibility criteria:
The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repetitive TMS | Experimental | Patients will receive 10 consecutive sessions of repetitive transcranial magnetic stimulation with the following protocol: Frequency: 10 Hz Intensity: 90% motor limiar Session duration: 16 minutes (20 sequencies of 6 seconds of stimulation followed by intervals of 30 seconds); Localization: Left pre-frontal dorsolateral cortex; |
|
| Sham TMS | Sham Comparator | Patients will receive 10 consecutive sessions of sham transcranial magnetic stimulation following the same protocol as the intervention arm, but with no magnetic stimulation of the brain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Stimulator Magstim Rapid 2 | Device | All procedures will use the Magnetic Stimulator Magstim Rapid 2. Total of session: 10 rTMS protocol: Freqüency: 10 Hz Intensity: 90% limiar motor Session duration: 16 minutes (20 TMS sequences of 6 second with intervals of 30 seconds between each sequence) Location: Left dorsolateral pre-frontal cortex |
| Measure | Description | Time Frame |
|---|---|---|
| Change in apathy symptoms | Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ADAS-Cog scores | Improvement in ADAS-Cog scores between baseline and 12 weeks after treatment. | 12 weeks |
| Change in the Zarit Burden Scale | Reduction in the Zarit Burden Scale between baseline and 12 weeks after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment | Assessment of rTMS safety by the UKU scale. | 4th week, 8th week, 12th week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Breno S Diniz, MD, PhD | Contact | +55 31 97950860 | brenosatler@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Breno S Diniz, MD, PhD | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Minas Gerais | Recruiting | Belo Horizonte | Outside of U.S. | 30130-100 | Brazil |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D053609 | Lethargy |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham Magnetic Stimulator | Device | This intervention will follow the same protocol of the rTMS except that subjects will not receive magnetic stimulation of the brain. Total of session: 10 |
|
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| 12 weeks |
| Federal University of Minas Gerais | Recruiting | Belo Horizonte | Outside of U.S. | 30130-100 | Brazil |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |