Alzheimer's Disease, Apathy
Conditions
Keywords
Apathy; Alzheimer's disease; Cognition; Burden of Care
Brief summary
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.
Detailed description
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: * Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20); * Diagnosis of apathy; * age between 60 and 85 years-old; * On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment; The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.
Interventions
DEVICEMagnetic Stimulator Magstim Rapid 2
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
DEVICESham Magnetic Stimulator
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
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age between 60 to 85 years-old * Mild or moderate Alzheimer's disease (MMSE scores between 10 and 20) * Apathy diagnosis * On stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment
Exclusion criteria
* history of epilepsy or convulsions * History of migraine or headaches episodes twice per week or more * History of neurodegenerative diseases other than Alzheimer's disease * Current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants * History of cerebral ischemic episode
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in apathy symptoms | 12 weeks | Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ADAS-Cog scores | 12 weeks | Improvement in ADAS-Cog scores between baseline and 12 weeks after treatment. |
| Change in the Zarit Burden Scale | 12 weeks | Reduction in the Zarit Burden Scale between baseline and 12 weeks after treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment | 4th week, 8th week, 12th week | Assessment of rTMS safety by the UKU scale. |
Countries
Brazil
Contacts
Primary ContactBreno S Diniz, MD, PhD
Outcome results
None listed