Theta-burst Stimulation on Cognitive Function in the Patients With Young-onset Alzheimer's Disease Dementia

NCT04042532 | Enrolling By Invitation

• 1 other identifier: 201802104A0
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease, Early Onset

Keywords

Young-onset dementia; Alzheimer's disease; rTMS; TBS

Outcome Measures

Primary Outcomes (4)

• Change from baseline MMSE total scores immediately after TBS intervention

  The changes of Mini-Mental State Examination (MMSE) total scores (score range from 0 to 30, higher values represent a better cognitive outcome)

  Before and immediately after TBS intervention

• Change from baseline MMSE total scores 4 weeks after TBS intervention

  The changes of Mini-Mental State Examination (MMSE) total scores (score range from 0 to 30, higher values represent a better cognitive outcome)

  Before and 4 weeks after TBS intervention

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

  The changes of Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) total scores (score range from 0 to 70, higher score indicates a worse cognitive outcome)

  Before and immediately after TBS intervention

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

  The changes of Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) total scores (score range from 0 to 70, higher score indicates a worse cognitive outcome)

  Before and 4 weeks after TBS intervention

Secondary Outcomes (1)

• The standard uptake values changes of FDG-PET

  Before and 1 week after TBS intervention

Study Arms (3)

Active group

ACTIVE COMPARATOR

Active group will receive active stimulation of standard intermittent TBS (iTBS) protocol.

Device: Theta-burst stimulation (TBS)

Sham group

SHAM COMPARATOR

Sham group will receive sham stimulation of the same iTBS protocol with the coil set at 90 to the skull.

Device: Theta-burst stimulation (TBS)

Cognitively normal control

NO INTERVENTION

Cognitively normal controls will be recruited for neuroimaging comparison.

Interventions

Theta-burst stimulation (TBS) DEVICE

We will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, we will give two sessions of iTBS separated by 15 min.

Active group; Sham group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Any subject has allergic reaction to 18F-florbetapir or 18F-FDG radiotracers.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Guishan, 333, Taiwan

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• KUAN YI WU

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2019
• First Posted: August 2, 2019
• Study Start: January 3, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)