Mild to Moderate Alzheimer DiseaseNCT04260724
Study on the Effect of Transcranial Magnetic Stimulation in Mild to Moderate Alzheimer's Disease
A study testing TMS in people with Mild to Moderate Alzheimer Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI before and after 4-week transcranial magnetic stimulation in patients with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild to Moderate Alzheimer Disease
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Feb 2020to 7 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who visited memory clinic of Samsung Medical Center
- aged 55 ~ 90
- diagnosed as probable Alzheimer dementia according to NIA-AA guideline 2011, or MCI patiens with amyloid PET positivity
- below -1SD in SVLTdelayed recall test and RCFT delayed recall test
- K-MMSE >=18
- no epileptic discharge in EEG
Show all 10Show fewer
- no history of epilepsy
- no arrhythmia or MI in ECG
- can read and write Korean (literate)
- volunteer and agree to the registration
Who cannot join
- no other neurologic deficit which can cause dementia except for Alzheimer's disease
- paitient who has severe cerebral white matter hyperintensities. (deep white matter >=2.5cm and caps or band >=1.0 cm)
- patients with severe medical disease including caner and ishemic heart disease
- claustrophobia or allergic to contrast of MRI
- medical deviced which is not removable (e.g pacemaker, cochlear implantation, dental prosthesis)
- history of brain surgery, and intervension or surgery of intra/extracranial artery(e.g. carotid artery stent insertion, CEA)
Show all 12Show fewer
- patient with dyspnea during resting
- history of loss of consciousness for more than 1 hour except for general anesthesia
- patients who cannot read written material because of poor visual acuity
- patients who cannot communicate because of severe hearing difficulty
- history of ototoxicity medication or exposure severe noises
- determined as inapropriate to participate clinical trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, 135-710
Sun Young Lee, +82-2-3410-3788, l2sy82@hanmail.net
About this study
Official title: Prospective, Randomized, Evaluator-blind, Single Center Study on the Effect of Transcranial Magnetic Stimulation in Mild to Moderate Alzheimer's Disease
The investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI before and after 4-week transcranial magnetic stimulation in patients with mild to moderate Alzheimer's disease.
The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.
Read the detailed description
Each 16 patients will be allocated to TMS group and sham coil group. Before TMS/sham coil stimulation, the investigators will take fMRI of each patient, and figure out which focus has strongest connectivity to hippocampus among lateral parietal regions of the brain. The investigators will fix the TSM transduced and apply accurate TMS stimulation to the focus using personalized frames. The investigators will make the frame using 3D printing technology.
After 4 week- TMS stimulation, the investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI beween baseline and after intervention. The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.
- Conditions
- Mild to Moderate Alzheimer Disease
- Being tested
- TMS, sham coil stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
- stimulation intensity : motor threshold 100%
- stimulation frequency : 1600 pulses for 20 minutes
- stimulation duration :for four weaks, 20 minutes/day, 5 days per week (Monday - Friday )
sham coil stimulationDevice
no stimulation Although the sound from device during stimulation is similar, no stimulation is applied.
| Study group | Role | What they receive |
|---|---|---|
| TMS group | Active comparator | Transcranial magnetic stimulation for four weeks Receives: Device: TMS |
| Sham group | Sham comparator | sham coil stimulation for four weeks (Although the sound of sham coil is the same to that of real TMS during intervension, no stimulation is applied. ) Receives: Device: sham coil stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the short term change of K-MMSE score in TMS group
the short term change of K-MMSE (Korean version of mini mental status exam) score in TMS group
Measured: 4 weeks
the short term change of K-MoCA score in TMS group
the short term change of K-MoCA (Korean version of Montreal cognitive assessment) score in TMS group
Measured: 4 weeks
the short term change of ADAS-Cog score in TMS group
the short term change of ADAS-Cog(the Alzheimer's disease assessment scale-cognitive subscale) score in TMS group
Measured: 4 weeks
the short term change of COWAT score in TMS group
the short term change of COWAT(controlled oral word association) score in TMS group
Measured: 4 weeks
the short term change of Stroop score in TMS group
the short term change of Stroop score in TMS group
Measured: 4 weeks
the short term change of TMT score in TMS group
the short term change of TMT(trail-making test) score in TMS group
Measured: 4 weeks
the short term change of RVP score in TMS group
the short term change of RVP(raid visual information processing) score in TMS group
Measured: 4 weeks
the short term change of SWM score in TMS group
the short term change of SWM (spatial working memory) score in TMS group
Measured: 4 weeks
the short term change of PRM score in TMS group
the short term change of PRM(pattern recognition memory) score in TMS group
Measured: 4 weeks
Secondary outcomes (40)
the long term change of K-MMSE score in TMS group
the long term change of K-MMSE (Korean version of mini mental status exam) score in TMS group
Measured: 8 weeks
the long term change of K-MoCA score in TMS group
the long term change of K-MoCA (Korean version of Montreal cognitive assessment) score in TMS group
Measured: 8 weeks
the long term change of ADAS-Cog score in TMS group
the long term change of ADAS-Cog(the Alzheimer's disease assessment scale-cognitive subscale) score in TMS group
Measured: 8 weeks
the long term change of COWAT score in TMS group
the long term change of COWAT(controlled oral word association) score in TMS group
Measured: 8 weeks
the long term change of Stroop score in TMS group
the long term change of Stroop score in TMS group
Measured: 8 weeks
the long term change of TMT score in TMS group
the long term change of TMT(trail-making test) score in TMS group
Measured: 8 weeks
the long term change of RVP score in TMS group
the long term change of RVP(raid visual information processing) score in TMS group
Measured: 8 weeks
the long term change of SWM score in TMS group
the long term change of SWM (spatial working memory) score in TMS group
Measured: 8 weeks
the long term change of PRM score in TMS
the long term change of PRM(pattern recognition memory) score in TMS group
Measured: 8 weeks
the change of ADL(activity of daily life) in TMS group
the score change of S-IADL(Seoul-Instrumental activities of daily life)
Measured: 4 weeks
the short term change of mood (depression) in TMS group
the score change of GDS(geriatric depression scale) short form
Measured: 4 weeks
the long term change of mood (depression) in TMS group
the score change of GDS(geriatric depression scale) short form
Measured: 8 weeks
the change of brain function in TMS group
the qualititve change of resting functional MRI
Measured: 4 weeks
the change of brain structure in TMS group
the change of FA (fractional anisotropy) value in DTI (diffusion tensor imaging) analysis
Measured: 4 weeks
the comparison of short term change of K-MMSE score between TMS group and sham group
the score change of K-MMSE (Korean version of mini mental status exam)
Measured: 4 weeks
the comparison of short term change of K-MoCA score between TMS group and sham group
the score change of K-MoCA (Korean version of Montreal cognitive assessment)
Measured: 4 weeks
the comparison of short term change of CDR-SOB between TMS group and sham group
the score change of CDR-SOB (Clinical dementia rating-sum of boxes)
Measured: 4 weeks
the comparison of short term change of ADAS-Cog between TMS group and sham group
the score change of ADAS-Cog ( the Alzheimer's disease assessment scale-cognitive subscale)
Measured: 4 weeks
the comparison of short term change of COWAT score between TMS group and sham group
the score change of COWAT(controlled oral word association) score
Measured: 4 weeks
the comparison of short term change of Stroop test score between TMS group and sham group
the score change of Stroop test score
Measured: 4 weeks
the comparison of short term change of TMT between TMS group and sham group
the score change of TMT (trail making test)
Measured: 4 weeks
the comparison of short term change of RVP score between TMS group and sham group
the score change of RVP(raid visual information processing) score
Measured: 4 weeks
the comparison of short term change of SWM between TMS group and sham group
the score change of SWM (spatial working memory) score
Measured: 4 weeks
the comparison of short term change of PRM between TMS group and sham group
the score change of PRM(pattern recognition memory) score
Measured: 4 weeks
the comparison of change of K-MMSE between TMS group and sham group
the score change of K-MMSE(Korean version of mini mental status exam)
Measured: 8 weeks
the comparison of long term change of K-MoCA between TMS group and sham group
the score change of K-MoCA (Korean version of Montreal cognitive assessment)
Measured: 8 weeks
the comparison of long term change of CDR-SOB between TMS group and sham group
the score change of CDR-SOB(Clinical dementia rating-sum of boxes)
Measured: 8 weeks
the comparison of long term change of ADAS-Cog between TMS group and sham group
the score change of ADAS-Cog ( the Alzheimer's disease assessment scale-cognitive subscale)
Measured: 8 weeks
the comparison of long term change of COWAT score between TMS group and sham group
the score change of COWAT(controlled oral word association) score
Measured: 8 weeks
the comparison of long term change of stroop test score between TMS group and sham group
the score change of stroop test score
Measured: 8 weeks
the comparison of long term change of TMT score between TMS group and sham group
the score change of TMT(trail making test)
Measured: 8 weeks
the comparison of long term change of RVP score between TMS group and sham group
the score change of RVP(raid visual information processing)
Measured: 8 weeks
the comparison of long term change of SWM score between TMS group and sham group
the score change of SWM (spatial working memory) score
Measured: 8 weeks
the comparison of long term change of cognitive function between TMS group and sham group
the score change of PRM(pattern recognition memory) score
Measured: 8 weeks
the comparison of short term change of mood (depression) between TMS group and sham group
the score change of GDS (geriatric depression scale) short form
Measured: 4 weeks
the comparison of long term change of mood (depression) between TMS group and sham group
the score change of GDS (geriatric depression scale) short form
Measured: 8 weeks
the comparison of short term change of ADL between TMS group and sham group
the score change of S-IADL(Seoul instrumental activity of daily life )
Measured: 4 weeks
the comparison of long term change of ADL between TMS group and sham group
the score change of S-IADL(Seoul instrumental activity of daily life )
Measured: 8 weeks
the comparison of change of resting fMRI between TMS group and sham group
the qualititve change of resting fMRI
Measured: 4 weeks
the comparison of change of FA value between TMS group and sham group
the change of FA(fractional anisotropy) value in DTI(diffusion tensor imaging) analysis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start7 Feb 2020 (estimated)
- Primary completion7 Feb 2021 (estimated)
- Study completion7 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duk Lyul Na, Samsung Medical Center
- Investigators
- Duk L Na, MD PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260724
- Sponsor's protocol ID
- SMC_2019-04-010-004
- Status last verified
- Feb 2020
- First submitted
- 22 Jan 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nilakantan AS, Mesulam MM, Weintraub S, Karp EL, VanHaerents S, Voss JL. Network-targeted stimulation engages neurobehavioral hallmarks of age-related memory decline. Neurology. 2019 May 14;92(20):e2349-e2354. doi: 10.1212/WNL.0000000000007502. Epub 2019 Apr 17.
PubMed 30996057Cotelli M, Manenti R, Cappa SF, Geroldi C, Zanetti O, Rossini PM, Miniussi C. Effect of transcranial magnetic stimulation on action naming in patients with Alzheimer disease. Arch Neurol. 2006 Nov;63(11):1602-4. doi: 10.1001/archneur.63.11.1602.
PubMed 17101829Cotelli M, Calabria M, Manenti R, Rosini S, Zanetti O, Cappa SF, Miniussi C. Improved language performance in Alzheimer disease following brain stimulation. J Neurol Neurosurg Psychiatry. 2011 Jul;82(7):794-7. doi: 10.1136/jnnp.2009.197848. Epub 2010 Jun 23.
PubMed 20574108Cotelli M, Manenti R, Cappa SF, Zanetti O, Miniussi C. Transcranial magnetic stimulation improves naming in Alzheimer disease patients at different stages of cognitive decline. Eur J Neurol. 2008 Dec;15(12):1286-92. doi: 10.1111/j.1468-1331.2008.02202.x.
PubMed 19049544Wang JX, Rogers LM, Gross EZ, Ryals AJ, Dokucu ME, Brandstatt KL, Hermiller MS, Voss JL. Targeted enhancement of cortical-hippocampal brain networks and associative memory. Science. 2014 Aug 29;345(6200):1054-7. doi: 10.1126/science.1252900.
PubMed 25170153Koch G, Bonni S, Pellicciari MC, Casula EP, Mancini M, Esposito R, Ponzo V, Picazio S, Di Lorenzo F, Serra L, Motta C, Maiella M, Marra C, Cercignani M, Martorana A, Caltagirone C, Bozzali M. Transcranial magnetic stimulation of the precuneus enhances memory and neural activity in prodromal Alzheimer's disease. Neuroimage. 2018 Apr 1;169:302-311. doi: 10.1016/j.neuroimage.2017.12.048. Epub 2017 Dec 19.
PubMed 29277405Ridding MC, Rothwell JC. Is there a future for therapeutic use of transcranial magnetic stimulation? Nat Rev Neurosci. 2007 Jul;8(7):559-67. doi: 10.1038/nrn2169.
PubMed 17565358Bondi MW, Edmonds EC, Jak AJ, Clark LR, Delano-Wood L, McDonald CR, Nation DA, Libon DJ, Au R, Galasko D, Salmon DP. Neuropsychological criteria for mild cognitive impairment improves diagnostic precision, biomarker associations, and progression rates. J Alzheimers Dis. 2014;42(1):275-89. doi: 10.3233/JAD-140276.
PubMed 24844687Weissman MM, Myers JK, Tischler GL, Holzer CE 3rd, Leaf PJ, Orvaschel H, Brody JA. Psychiatric disorders (DSM-III) and cognitive impairment among the elderly in a U.S. urban community. Acta Psychiatr Scand. 1985 Apr;71(4):366-79. doi: 10.1111/j.1600-0447.1985.tb02536.x.
PubMed 4003102Kim S, Nilakantan AS, Hermiller MS, Palumbo RT, VanHaerents S, Voss JL. Selective and coherent activity increases due to stimulation indicate functional distinctions between episodic memory networks. Sci Adv. 2018 Aug 22;4(8):eaar2768. doi: 10.1126/sciadv.aar2768. eCollection 2018 Aug.
PubMed 30140737Jung YH, Jang H, Park S, Kim HJ, Seo SW, Kim GB, Shon YM, Kim S, Na DL. Effectiveness of Personalized Hippocampal Network-Targeted Stimulation in Alzheimer Disease: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e249220. doi: 10.1001/jamanetworkopen.2024.9220.
PubMed 38709534
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Evaluator-blind, Single Center Study on the Effect of Transcranial Magnetic Stimulation in Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04260724
- Acronym / sponsor ID
- SMC_2019-04-010-004
- Conditions
- Mild to Moderate Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 7 Feb 2020 (estimated)
- Primary completion
- 7 Feb 2021 (estimated)
- Study completion
- 7 Feb 2022 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI before and after 4-week transcranial magnetic stimulation in patients with mild to moderate Alzheimer's disease.
The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.
Detailed description
Each 16 patients will be allocated to TMS group and sham coil group. Before TMS/sham coil stimulation, the investigators will take fMRI of each patient, and figure out which focus has strongest connectivity to hippocampus among lateral parietal regions of the brain. The investigators will fix the TSM transduced and apply accurate TMS stimulation to the focus using personalized frames. The investigators will make the frame using 3D printing technology.
After 4 week- TMS stimulation, the investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI beween baseline and after intervention. The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS group | Active comparator | Device: TMSTranscranial magnetic stimulation for four weeks |
| Sham group | Sham comparator | Device: sham coil stimulationsham coil stimulation for four weeks (Although the sound of sham coil is the same to that of real TMS during intervension, no stimulation is applied. ) |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- patients who visited memory clinic of Samsung Medical Center
- aged 55 ~ 90
- diagnosed as probable Alzheimer dementia according to NIA-AA guideline 2011, or MCI patiens with amyloid PET positivity
- below -1SD in SVLTdelayed recall test and RCFT delayed recall test
- K-MMSE >=18
Key exclusion criteria (12 listed)
- no other neurologic deficit which can cause dementia except for Alzheimer's disease
- paitient who has severe cerebral white matter hyperintensities. (deep white matter >=2.5cm and caps or band >=1.0 cm)
- patients with severe medical disease including caner and ishemic heart disease
- claustrophobia or allergic to contrast of MRI
- medical deviced which is not removable (e.g pacemaker, cochlear implantation, dental prosthesis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS* stimulation intensity : motor threshold 100% * stimulation frequency : 1600 pulses for 20 minutes * stimulation duration :for four weaks, 20 minutes/day, 5 days per week (Monday - Friday ) | Device | TMS group |
| sham coil stimulationno stimulation Although the sound from device during stimulation is similar, no stimulation is applied. | Device | Sham group |
Primary outcome
the short term change of K-MMSE score in TMS group
Time frame: 4 weeks
the short term change of K-MMSE (Korean version of mini mental status exam) score in TMS group
the short term change of K-MoCA score in TMS group
Time frame: 4 weeks
the short term change of K-MoCA (Korean version of Montreal cognitive assessment) score in TMS group
the short term change of ADAS-Cog score in TMS group
Time frame: 4 weeks
the short term change of ADAS-Cog(the Alzheimer's disease assessment scale-cognitive subscale) score in TMS group
the short term change of COWAT score in TMS group
Time frame: 4 weeks
the short term change of COWAT(controlled oral word association) score in TMS group
the short term change of Stroop score in TMS group
Time frame: 4 weeks
the short term change of Stroop score in TMS group
the short term change of TMT score in TMS group
Time frame: 4 weeks
the short term change of TMT(trail-making test) score in TMS group
the short term change of RVP score in TMS group
Time frame: 4 weeks
the short term change of RVP(raid visual information processing) score in TMS group
the short term change of SWM score in TMS group
Time frame: 4 weeks
the short term change of SWM (spatial working memory) score in TMS group
the short term change of PRM score in TMS group
Time frame: 4 weeks
the short term change of PRM(pattern recognition memory) score in TMS group
40 secondary outcomes
the long term change of K-MMSE score in TMS group
Time frame: 8 weeks
the long term change of K-MoCA score in TMS group
Time frame: 8 weeks
the long term change of ADAS-Cog score in TMS group
Time frame: 8 weeks
the long term change of COWAT score in TMS group
Time frame: 8 weeks
the long term change of Stroop score in TMS group
Time frame: 8 weeks
the long term change of TMT score in TMS group
Time frame: 8 weeks
the long term change of RVP score in TMS group
Time frame: 8 weeks
the long term change of SWM score in TMS group
Time frame: 8 weeks
the long term change of PRM score in TMS
Time frame: 8 weeks
the change of ADL(activity of daily life) in TMS group
Time frame: 4 weeks
the short term change of mood (depression) in TMS group
Time frame: 4 weeks
the long term change of mood (depression) in TMS group
Time frame: 8 weeks
the change of brain function in TMS group
Time frame: 4 weeks
the change of brain structure in TMS group
Time frame: 4 weeks
the comparison of short term change of K-MMSE score between TMS group and sham group
Time frame: 4 weeks
the comparison of short term change of K-MoCA score between TMS group and sham group
Time frame: 4 weeks
the comparison of short term change of CDR-SOB between TMS group and sham group
Time frame: 4 weeks
the comparison of short term change of ADAS-Cog between TMS group and sham group
Time frame: 4 weeks
the comparison of short term change of COWAT score between TMS group and sham group
Time frame: 4 weeks
the comparison of short term change of Stroop test score between TMS group and sham group
Time frame: 4 weeks
the comparison of short term change of TMT between TMS group and sham group
Time frame: 4 weeks
the comparison of short term change of RVP score between TMS group and sham group
Time frame: 4 weeks
the comparison of short term change of SWM between TMS group and sham group
Time frame: 4 weeks
the comparison of short term change of PRM between TMS group and sham group
Time frame: 4 weeks
the comparison of change of K-MMSE between TMS group and sham group
Time frame: 8 weeks
the comparison of long term change of K-MoCA between TMS group and sham group
Time frame: 8 weeks
the comparison of long term change of CDR-SOB between TMS group and sham group
Time frame: 8 weeks
the comparison of long term change of ADAS-Cog between TMS group and sham group
Time frame: 8 weeks
the comparison of long term change of COWAT score between TMS group and sham group
Time frame: 8 weeks
the comparison of long term change of stroop test score between TMS group and sham group
Time frame: 8 weeks
the comparison of long term change of TMT score between TMS group and sham group
Time frame: 8 weeks
the comparison of long term change of RVP score between TMS group and sham group
Time frame: 8 weeks
the comparison of long term change of SWM score between TMS group and sham group
Time frame: 8 weeks
the comparison of long term change of cognitive function between TMS group and sham group
Time frame: 8 weeks
the comparison of short term change of mood (depression) between TMS group and sham group
Time frame: 4 weeks
the comparison of long term change of mood (depression) between TMS group and sham group
Time frame: 8 weeks
the comparison of short term change of ADL between TMS group and sham group
Time frame: 4 weeks
the comparison of long term change of ADL between TMS group and sham group
Time frame: 8 weeks
the comparison of change of resting fMRI between TMS group and sham group
Time frame: 4 weeks
the comparison of change of FA value between TMS group and sham group
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 30996057Nilakantan AS, Mesulam MM, Weintraub S, Karp EL, VanHaerents S, Voss JL. Network-targeted stimulation engages neurobehavioral hallmarks of age-related memory decline. Neurology. 2019 May 14;92(20):e2349-e2354. doi: 10.1212/WNL.0000000000007502. Epub 2019 Apr 17.
- Background: PubMed 17101829Cotelli M, Manenti R, Cappa SF, Geroldi C, Zanetti O, Rossini PM, Miniussi C. Effect of transcranial magnetic stimulation on action naming in patients with Alzheimer disease. Arch Neurol. 2006 Nov;63(11):1602-4. doi: 10.1001/archneur.63.11.1602.
- Background: PubMed 20574108Cotelli M, Calabria M, Manenti R, Rosini S, Zanetti O, Cappa SF, Miniussi C. Improved language performance in Alzheimer disease following brain stimulation. J Neurol Neurosurg Psychiatry. 2011 Jul;82(7):794-7. doi: 10.1136/jnnp.2009.197848. Epub 2010 Jun 23.
- Background: PubMed 19049544Cotelli M, Manenti R, Cappa SF, Zanetti O, Miniussi C. Transcranial magnetic stimulation improves naming in Alzheimer disease patients at different stages of cognitive decline. Eur J Neurol. 2008 Dec;15(12):1286-92. doi: 10.1111/j.1468-1331.2008.02202.x.
- Background: PubMed 25170153Wang JX, Rogers LM, Gross EZ, Ryals AJ, Dokucu ME, Brandstatt KL, Hermiller MS, Voss JL. Targeted enhancement of cortical-hippocampal brain networks and associative memory. Science. 2014 Aug 29;345(6200):1054-7. doi: 10.1126/science.1252900.
- Background: PubMed 29277405Koch G, Bonni S, Pellicciari MC, Casula EP, Mancini M, Esposito R, Ponzo V, Picazio S, Di Lorenzo F, Serra L, Motta C, Maiella M, Marra C, Cercignani M, Martorana A, Caltagirone C, Bozzali M. Transcranial magnetic stimulation of the precuneus enhances memory and neural activity in prodromal Alzheimer's disease. Neuroimage. 2018 Apr 1;169:302-311. doi: 10.1016/j.neuroimage.2017.12.048. Epub 2017 Dec 19.
- Background: PubMed 17565358Ridding MC, Rothwell JC. Is there a future for therapeutic use of transcranial magnetic stimulation? Nat Rev Neurosci. 2007 Jul;8(7):559-67. doi: 10.1038/nrn2169.
- Background: PubMed 24844687Bondi MW, Edmonds EC, Jak AJ, Clark LR, Delano-Wood L, McDonald CR, Nation DA, Libon DJ, Au R, Galasko D, Salmon DP. Neuropsychological criteria for mild cognitive impairment improves diagnostic precision, biomarker associations, and progression rates. J Alzheimers Dis. 2014;42(1):275-89. doi: 10.3233/JAD-140276.
- Background: PubMed 4003102Weissman MM, Myers JK, Tischler GL, Holzer CE 3rd, Leaf PJ, Orvaschel H, Brody JA. Psychiatric disorders (DSM-III) and cognitive impairment among the elderly in a U.S. urban community. Acta Psychiatr Scand. 1985 Apr;71(4):366-79. doi: 10.1111/j.1600-0447.1985.tb02536.x.
- Results publication: PubMed 30140737Kim S, Nilakantan AS, Hermiller MS, Palumbo RT, VanHaerents S, Voss JL. Selective and coherent activity increases due to stimulation indicate functional distinctions between episodic memory networks. Sci Adv. 2018 Aug 22;4(8):eaar2768. doi: 10.1126/sciadv.aar2768. eCollection 2018 Aug.
- Derived from this study: PubMed 38709534Jung YH, Jang H, Park S, Kim HJ, Seo SW, Kim GB, Shon YM, Kim S, Na DL. Effectiveness of Personalized Hippocampal Network-Targeted Stimulation in Alzheimer Disease: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e249220. doi: 10.1001/jamanetworkopen.2024.9220.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duk L Na, MD PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Mild to Moderate Alzheimer Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Hee Jung, MD PhD (82-10-6755-5462, neophilia1618@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the short term change of K-MMSE score in TMS group (time frame: 4 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04260724, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.