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CompletedNCT05440110SNAPUpdated Mar 23, 2026

Cognitive Effects of Theta-burst Stimulation (TBS) in Suspected Non-Alzheimer Disease Pathophysiology (SNAP)

An interventional study of active and active TBS and sham and active TBS in Suspected Non-Alzheimer Disease Pathophysiology (SNAP), sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study summary

This is a pilot study to identify a homogeneous cohort of pathologically specific dementia with SNAP for clinical trial of brain stimulation.

Read the detailed description

The investigators apply the NIA-AA criteria to identify the individuals of biomarker-defined SNAP endophenotype. This is a prospective, randomized controlled clinical trial for the first two weeks, followed by an open-label trial for the next two weeks, and combined functional neuroimaging study of 18F-FDG-PET to further explore the potential mechanisms. A total of 20 SNAP dementia patients will be recruited for consecutive two years, and be subjected to iTBS for 5 daily interventions per week for four consecutive weeks. Cognitive evaluation will be performed before and immediately after TBS intervention, and 8 weeks after TBS. Data on functional neuroimaging will be also collected before and after TBS protocol.

02

Conditions studied

  • Suspected Non-Alzheimer Disease Pathophysiology (SNAP)

Keywords

  • Suspected Non-Alzheimer Disease Pathophysiology (SNAP)
  • theta-burst stimulation
  • repetitive transcranial magnetic stimulation (rTMS)
03

In context

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects aged 50-90 year.
  2. Patients meet NIA-AA research criteria for suspected non-Alzheimer disease pathophysiology (SNAP) (Petersen, Smith et al. 1999; Jack, Bennett et al. 2018), and DSM-5 criteria for major neurocognitive disorder of dementia (Regier, Narrow et al. 2013).
  3. Amyloid PET should ever be performed.
  4. The CDR of subjects can be 0.5-2.

Exclusion criteria

Exclusion Criteria:

  1. Any subject has a definite diagnosis of epilepsy or history of seizure attack.
  2. Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor. (cerebrovascular disorders, hydrocephalus and intra-cranial mass, documented by MRI; a history of traumatic brain injury or another neurological disease).
  3. 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.
  4. Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia, bipolar disorder, and previously prolonged substances abuse.
  5. Any females who is pregnant or lactating.
  6. 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 MR compatible in the body.

Withdrawal criteria

  1. Complications onset after intervention that affect efficacy and safety judgments.
  2. New onset or progression of disease that may affect outcomes.
  3. Use of other therapies or drugs during the intervention period to change cognitive functions.
  4. Any subjects who are recognized as high risk of adverse effects by principle investigator.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
17 participants (actual)

Study arms

  • Active comparator
    active and active

    The patients will be subjected to TBS for 5 daily interventions per week for four consecutive weeks.

    Device: active and active TBS

  • Sham comparator
    sham and active

    The patients will be subjected to TBS for 5 daily interventions per week for the first two weeks, followed by an open-label trial for the next two weeks.

    Device: sham and active TBS

Interventions

  • Deviceactive and active TBS

    The investigators 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, The investigators will give two sessions of iTBS separated by 15 min.

  • Devicesham and active TBS

    The investigators 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, The investigators will give two sessions of iTBS separated by 15 min. Sham stimulation applies the same iTBS protocol with the sham coil.

06

What researchers measure

Primary outcomes

  1. The changes of Mini-Mental State Examination (MMSE) total scores

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

    Time frame: baseline (T0) and immediately after 2 weeks of TBS (T2), and 4 weeks of TBS (T4), and 8-week follow-up after TBS (T12)

  2. The changes of Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) total scores

    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)

    Time frame: baseline (T0) and immediately after 2 weeks of TBS (T2), and 4 weeks of TBS (T4), and 8-week follow-up after TBS (T12)

Secondary outcomes

  1. The standard uptake values changes of FDG-PET

    The standard uptake values (SUV) changes of cerebral glucose metabolism using 18F-FDG-PET

    Time frame: baseline (T0) and immediately after 2 weeks of TBS (T2), and 4 weeks of TBS (T4)

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taoyuan, Guishan 333, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05440110
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Jun 30, 2022
Start date
Oct 18, 2022
Primary completion
Aug 15, 2025
Completion
Nov 30, 2025
Last update
Mar 23, 2026

Study contacts

KUAN YI WU
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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