Theta-burst Stimulation on Cognitive Function in the Patients With Young-onset Alzheimer's Diseas… (NCT04042532) | Clinical Trial Compass
By InvitationNot Applicable
Theta-burst Stimulation on Cognitive Function in the Patients With Young-onset Alzheimer's Disease Dementia
Taiwan70 participantsStarted 2020-01-03
Plain-language summary
Young-onset dementia (YOD) is a devastating condition, and it produces substantial psychosocial impacts on individual's functioning and family's care burden. Alzheimer's disease (AD) dementia is the most common type in YOD. Medication treatment Response was limited and unsatisfactory. In recent years, repetitive transcranial magnetic stimulation (rTMS) has been considered an alternative for the improvement of cognition in older patients with cognitive impairment. This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with young-onset AD.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Any patient has a definite diagnosis of AD dementia according to the NIA-AA criteria for intermediate-to-high levels of biological evidence of probable and possible AD dementia (McKhann et al. 2011).
. Dementia onset before age 65 years old.
. Age between 50-75 years old for patient and control group.
. The severity of dementia is limited to mild to moderate stage in current project. The definition of mild to moderate stage of dementia is based on the clinical dementia rating scale (CDR) from 0.5-2.
. Cognitively normal controls MMSE≧24, CDR should be 0.
. Informed consent provided by the patient and family.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline MMSE total scores immediately after TBS intervention
Timeframe: Before and immediately after TBS intervention
2
Change from baseline MMSE total scores 4 weeks after TBS intervention
Timeframe: Before and 4 weeks after TBS intervention
3
Change from baseline ADAS-Cog total scores immediately after TBS intervention
Timeframe: Before and immediately after TBS intervention
4
Change from baseline ADAS-Cog total scores 4 weeks after TBS intervention
Timeframe: Before and 4 weeks after TBS intervention
. Any subject has a definite diagnosis of epilepsy or history of seizure attack.
. Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
. Any subject has clinically significant or unstable medical diseases including metabolic, renal, liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders
. Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or previously prolonged history of substances abuse
. Any females who is pregnant or lactating
. General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not magnetic resonance (MR) compatible in the body.
. Any subject has allergic reaction to 18F-florbetapir or 18F-FDG radiotracers.