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 range50 Years – 75 Years

SexALL

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

✕. 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.

What they're measuring

Change from baseline MMSE total scores immediately after TBS intervention

Timeframe: Before and immediately after TBS intervention

Change from baseline MMSE total scores 4 weeks after TBS intervention

Timeframe: Before and 4 weeks after TBS intervention

Change from baseline ADAS-Cog total scores immediately after TBS intervention

Timeframe: Before and immediately after TBS intervention

Change from baseline ADAS-Cog total scores 4 weeks after TBS intervention

Timeframe: Before and 4 weeks after TBS intervention

Trial details

NCT IDNCT04042532

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Alzheimer Disease, Early Onset trials

Plain-language summary

Who can participate

Age range50 Years – 75 Years

SexALL

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

✕. 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.

What they're measuring

Change from baseline MMSE total scores immediately after TBS intervention

Timeframe: Before and immediately after TBS intervention

Change from baseline MMSE total scores 4 weeks after TBS intervention

Timeframe: Before and 4 weeks after TBS intervention

Change from baseline ADAS-Cog total scores immediately after TBS intervention

Timeframe: Before and immediately after TBS intervention

Change from baseline ADAS-Cog total scores 4 weeks after TBS intervention

Timeframe: Before and 4 weeks after TBS intervention