Dementia With Lewy Bodies (DLB)REACT-DLBNCT07846189
Rhythmic Entrainment and Alertness in Lewy Body Dementia
A study testing Rhythmic Auditory Cueing in people with Dementia With Lewy Bodies (DLB) and Lewy Body Dementia (LBD), run by Johns Hopkins University.
Trial summary
This study will examine how people with dementia with Lewy bodies (DLB) or mild cognitive impairment with Lewy bodies respond to rhythmic auditory cues, and whether changes in alertness affect ability to synchronize movements to a rhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia With Lewy Bodies (DLB), Lewy Body Dementia (LBD)
- What is being tested?
- Rhythmic Auditory Cueing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of probable dementia with Lewy bodies (DLB) or mild cognitive impairment with Lewy bodies (MCI-LB) based on established clinical diagnostic criteria
- Fluent in English
- Able to attend with a study partner who can complete care-partner-reported cognitive fluctuation measures
- Clinical Dementia Rating (CDR) global score of 0.5-1.0
- Adequate upper-limb motor function, defined as Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III finger-tapping item (3.4) score ≤2 on at least one hand and ability to sustain rhythmic tapping for at least 10 seconds at approximately 1-3 Hz during a brief practice trial
- Adequate hearing, corrected if necessary, to perceive rhythmic auditory cues
- Stable on all medications for at least 30 days before enrollment
Who cannot join
- Age younger than 18 years
- CDR global score ≥2.0
- Severe upper-limb impairment, defined as MDS-UPDRS Part III finger-tapping item (3.4) score ≥3 in the dominant hand, or inability to produce more than 10 consecutive taps at ≥1 Hz despite instruction/practice
- Other neurological, musculoskeletal, or sensory conditions that preclude safe or reliable task participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Rhythmic Entrainment and Alertness Co-modulating Test in Dementia With Lewy Bodies (REACT-DLB): Pilot Study
This study will examine how people with dementia with Lewy bodies (DLB) or mild cognitive impairment with Lewy bodies respond to rhythmic auditory cues, and whether changes in alertness affect ability to synchronize movements to a rhythm.
Participants will complete a single study visit that includes finger-tapping tasks performed with and without rhythmic auditory cues at different tempos. Brain activity will be recorded using electroencephalography (EEG), and tapping performance will be measured. Participants and the participant's study partners will also provide repeated ratings of alertness during the visit.
The study aims to identify brain and behavioral measures of rhythmic synchronization and determine whether these measures change depending on a participant's level of alertness. The findings will help guide the development of future rhythm-based interventions for people with DLB.
Read the detailed description
REACT-DLB is a single-session, within-participant mechanistic study designed to characterize neural and behavioral responses to rhythmic auditory cueing in individuals with probable dementia with Lewy bodies (DLB) or mild cognitive impairment with Lewy bodies. The target enrollment is 30 participants with a Clinical Dementia Rating (CDR) global score of 0.5-1.0, with balanced recruitment across CDR 0.5 and 1.0 when feasible.
Participants will first complete a self-paced finger-tapping trial to determine the participant's preferred tapping tempo. Participants will then complete six auditory-cued tapping trials at three tempo conditions: preferred tempo, 20% slower than preferred tempo, and 20% faster than preferred tempo. The tempo conditions will be presented in randomized order. EEG and finger-tapping responses will be recorded during the task.
The primary neural measure of rhythmic entrainment is beta-band event-related desynchronization (β-ERD), and the primary behavioral measure is inter-tap-interval coefficient of variation (ITI-CV). Exploratory measures include delta/theta inter-trial phase coherence (ITPC), mean asynchrony between taps and auditory cues, and continuation drift.
To evaluate whether momentary alertness influences rhythmic entrainment, participants and care partners will provide repeated Visual Analogue Scale ratings of alertness between tapping blocks, and brief eyes-open resting-state EEG recordings will be collected. The EEG theta/alpha ratio will be used as a neural index of alertness. Clinician- and care-partner-reported measures of cognitive fluctuation will also be collected. Analyses will examine whether alertness measures are associated with differences in neural and behavioral rhythmic entrainment.
For participants taking levodopa, study testing will be scheduled during the participant's best clinically defined ON state when applicable. If a clear best ON state cannot be identified, testing will occur within approximately one hour of medication administration. Participants not taking levodopa will be tested in the participant's usual clinically stable medication state.
The active finger-tapping component lasts approximately 13 minutes. Including rest periods and alertness assessments, the tapping-related portion is expected to take approximately 20-25 minutes. The entire study visit, including consent, questionnaires, EEG setup and recording, tapping tasks, and breaks, is expected to last approximately 90-120 minutes.
- Being tested
- Rhythmic Auditory Cueing
- Keywords
- rhythmic auditory stimulation, rhythmic entrainment, auditory-motor synchronization, electroencephalography (EEG), alertness, cognitive fluctuations
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Auditory CueingBehavioural
Participants will perform finger-tapping tasks while listening to rhythmic auditory cues presented at three tempo conditions: preferred tempo, 20% slower, and 20% faster. Each cued condition will be repeated twice in randomized order.
| Study group | Role | What they receive |
|---|---|---|
| Auditory-Cued Finger Tapping | Experimental | Participants will complete a single-session finger-tapping protocol. After a 1-minute self-paced tapping trial to determine preferred tempo, participants will complete six 2-minute auditory-cued tapping trials at three tempo conditions: preferred tempo, 20% slower, and 20% faster, with each condition repeated twice in randomized order. EEG and tapping responses will be recorded during the task, and alertness will be assessed between tapping blocks. Receives: Behavioral: Rhythmic Auditory Cueing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-band event-related desynchronization (β-ERD) during auditory-cued finger tapping
Beta-band event-related desynchronization (β-ERD; 13-30 Hz) will be derived from task-related EEG recorded during auditory-cued finger tapping. β-ERD is an EEG measure of sensorimotor activation and auditory-motor coupling during rhythmic movement. β-ERD will be compared across the three auditory cueing tempo conditions: preferred tempo, 20% slower than preferred tempo, and 20% faster than preferred tempo. Collected at a single study visit; during six 2-minute auditory-cued finger-tapping trials.
Measured: Day 1, during each of six 2-minute auditory-cued finger-tapping trials
Inter-tap interval coefficient of variation (ITI-CV) during auditory-cued finger tapping
Inter-tap interval coefficient of variation (ITI-CV) will be calculated from the timing of consecutive finger taps during auditory-cued finger tapping. ITI-CV measures variability in tapping intervals and serves as an index of motor-timing precision and rhythmic consistency, with lower values indicating more consistent tapping. ITI-CV will be compared across the three auditory cueing tempo conditions: preferred tempo, 20% slower than preferred tempo, and 20% faster than preferred tempo. Collected at a single study visit; during six 2-minute auditory-cued finger-tapping trials.
Measured: Day 1, during each of six 2-minute auditory-cued finger-tapping trials
Secondary outcomes (3)
EEG Alertness Index as assessed by theta/alpha ratio (TAR)
The EEG Alertness Index will be calculated as the frontal theta/posterior alpha ratio (TAR) from eyes-open resting-state EEG recordings collected between finger-tapping blocks. TAR is an EEG marker of cortical arousal, with higher TAR indicating lower alertness. TAR will be examined in relation to neural and behavioral rhythmic entrainment across auditory cueing conditions. Collected at a single study visit; during 2-minute eyes-open resting-state EEG recordings collected between tapping blocks
Measured: Day 1, during each 2-minute eyes-open resting-state EEG recording collected between finger-tapping blocks
Participant-reported alertness as assessed by Visual Analogue Scale (VAS)
Participants will provide repeated Visual Analogue Scale ratings of their momentary alertness between finger-tapping blocks. These ratings will be used to characterize within-session variation in alertness and examine its relationship with neural and behavioral measures of rhythmic entrainment. Scale 1-10 lower score better. Collected at a single study visit; assessed between tapping blocks.
Measured: Day 1, immediately after each of six 2-minute auditory-cued finger-tapping trials
Care-partner-reported participant alertness as assessed by Visual Analogue Scale (VAS)
Care partners will provide repeated Visual Analogue Scale ratings of the participant's momentary alertness between finger-tapping blocks. These ratings will provide an additional measure of within-session alertness variation and will be examined in relation to neural and behavioral measures of rhythmic entrainment. Scale 1-10 lower score better. Collected at a single study visit; assessed between tapping blocks.
Measured: Day 1, immediately after each of six 2-minute auditory-cued finger-tapping trials
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dementia With Lewy Bodies (DLB)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants complete the same single-session, within-subject protocol. Following a self-paced finger-tapping trial, participants complete six auditory-cued tapping trials across three tempo conditions (preferred tempo, 20% slower, and 20% faster), with each condition repeated twice in randomized order.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kyurim Kang, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846189
- Sponsor's protocol ID
- IRB00582709
- Other IDs
- U24AG084436
- Acronym
- REACT-DLB
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baik K, Jung JH, Jeong SH, Chung SJ, Yoo HS, Lee PH, Sohn YH, Kang SW, Ye BS. Implication of EEG theta/alpha and theta/beta ratio in Alzheimer's and Lewy body disease. Sci Rep. 2022 Nov 4;12(1):18706. doi: 10.1038/s41598-022-21951-5.
PubMed 36333386Pantelyat A, Dayanim G, Kang K, Turk B, Pagkatipunan R, Huenergard SK, Mears A, Bang J. Rhythmic auditory cueing in atypical parkinsonism: A pilot study. Front Neurol. 2022 Oct 28;13:1018206. doi: 10.3389/fneur.2022.1018206. eCollection 2022.
PubMed 36388209Stylianou M, Murphy N, Peraza LR, Graziadio S, Cromarty R, Killen A, O' Brien JT, Thomas AJ, LeBeau FEN, Taylor JP. Quantitative electroencephalography as a marker of cognitive fluctuations in dementia with Lewy bodies and an aid to differential diagnosis. Clin Neurophysiol. 2018 Jun;129(6):1209-1220. doi: 10.1016/j.clinph.2018.03.013. Epub 2018 Apr 3.
PubMed 29656189Donaghy PC, Carrarini C, Ferreira D, Habich A, Aarsland D, Babiloni C, Bayram E, Kane JP, Lewis SJ, Pilotto A, Thomas AJ, Bonanni L; Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment Lewy Body Dementias Prodromal Working Group. Research diagnostic criteria for mild cognitive impairment with Lewy bodies: A systematic review and meta-analysis. Alzheimers Dement. 2023 Jul;19(7):3186-3202. doi: 10.1002/alz.13105. Epub 2023 Apr 24.
PubMed 37096339McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7.
PubMed 28592453D'Antonio F, Kane JPM, Ibanez A, Lewis SJG, Camicioli R, Wang H, Yu Y, Zhang J, Ji Y, Borda MG, Kandadai RM, Babiloni C, Bonanni L, Ikeda M, Boeve BF, Leverenz JB, Aarsland D; ISTAART Lewy body dementias Consortia Working Group. Dementia with Lewy bodies research consortia: A global perspective from the ISTAART Lewy Body Dementias Professional Interest Area working group. Alzheimers Dement (Amst). 2021 Sep 14;13(1):e12235. doi: 10.1002/dad2.12235. eCollection 2021.
PubMed 34541289Rahimi J, Kovacs GG. Prevalence of mixed pathologies in the aging brain. Alzheimers Res Ther. 2014 Nov 21;6(9):82. doi: 10.1186/s13195-014-0082-1. eCollection 2014.
PubMed 25419243Mueller C, Ballard C, Corbett A, Aarsland D. The prognosis of dementia with Lewy bodies. Lancet Neurol. 2017 May;16(5):390-398. doi: 10.1016/S1474-4422(17)30074-1. Epub 2017 Mar 22.
PubMed 28342649
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythmic Entrainment and Alertness Co-modulating Test in Dementia With Lewy Bodies (REACT-DLB): Pilot Study
- ClinicalTrials.gov ID
- NCT07846189
- Acronym / sponsor ID
- REACT-DLB / IRB00582709
- Keywords
- rhythmic auditory stimulation, rhythmic entrainment, auditory-motor synchronization, electroencephalography (EEG), alertness, cognitive fluctuations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 29 Sep 2026 (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.
This study will examine how people with dementia with Lewy bodies (DLB) or mild cognitive impairment with Lewy bodies respond to rhythmic auditory cues, and whether changes in alertness affect ability to synchronize movements to a rhythm.
Participants will complete a single study visit that includes finger-tapping tasks performed with and without rhythmic auditory cues at different tempos. Brain activity will be recorded using electroencephalography (EEG), and tapping performance will be measured. Participants and the participant's study partners will also provide repeated ratings of alertness during the visit.
The study aims to identify brain and behavioral measures of rhythmic synchronization and determine whether these measures change depending on a participant's level of alertness. The findings will help guide the development of future rhythm-based interventions for people with DLB.
Detailed description
REACT-DLB is a single-session, within-participant mechanistic study designed to characterize neural and behavioral responses to rhythmic auditory cueing in individuals with probable dementia with Lewy bodies (DLB) or mild cognitive impairment with Lewy bodies. The target enrollment is 30 participants with a Clinical Dementia Rating (CDR) global score of 0.5-1.0, with balanced recruitment across CDR 0.5 and 1.0 when feasible.
Participants will first complete a self-paced finger-tapping trial to determine the participant's preferred tapping tempo. Participants will then complete six auditory-cued tapping trials at three tempo conditions: preferred tempo, 20% slower than preferred tempo, and 20% faster than preferred tempo. The tempo conditions will be presented in randomized order. EEG and finger-tapping responses will be recorded during the task.
The primary neural measure of rhythmic entrainment is beta-band event-related desynchronization (β-ERD), and the primary behavioral measure is inter-tap-interval coefficient of variation (ITI-CV). Exploratory measures include delta/theta inter-trial phase coherence (ITPC), mean asynchrony between taps and auditory cues, and continuation drift.
To evaluate whether momentary alertness influences rhythmic entrainment, participants and care partners will provide repeated Visual Analogue Scale ratings of alertness between tapping blocks, and brief eyes-open resting-state EEG recordings will be collected. The EEG theta/alpha ratio will be used as a neural index of alertness. Clinician- and care-partner-reported measures of cognitive fluctuation will also be collected. Analyses will examine whether alertness measures are associated with differences in neural and behavioral rhythmic entrainment.
For participants taking levodopa, study testing will be scheduled during the participant's best clinically defined ON state when applicable. If a clear best ON state cannot be identified, testing will occur within approximately one hour of medication administration. Participants not taking levodopa will be tested in the participant's usual clinically stable medication state.
The active finger-tapping component lasts approximately 13 minutes. Including rest periods and alertness assessments, the tapping-related portion is expected to take approximately 20-25 minutes. The entire study visit, including consent, questionnaires, EEG setup and recording, tapping tasks, and breaks, is expected to last approximately 90-120 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants complete the same single-session, within-subject protocol. Following a self-paced finger-tapping trial, participants complete six auditory-cued tapping trials across three tempo conditions (preferred tempo, 20% slower, and 20% faster), with each condition repeated twice in randomized order.
| Arm | Type | Receives |
|---|---|---|
| Auditory-Cued Finger Tapping | Experimental | Behavioral: Rhythmic Auditory CueingParticipants will complete a single-session finger-tapping protocol. After a 1-minute self-paced tapping trial to determine preferred tempo, participants will complete six 2-minute auditory-cued tapping trials at three tempo conditions: preferred tempo, 20% slower, and 20% faster, with each condition repeated twice in randomized order. EEG and tapping responses will be recorded during the task, and alertness will be assessed between tapping blocks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Diagnosis of probable dementia with Lewy bodies (DLB) or mild cognitive impairment with Lewy bodies (MCI-LB) based on established clinical diagnostic criteria
- Fluent in English
- Able to attend with a study partner who can complete care-partner-reported cognitive fluctuation measures
- Clinical Dementia Rating (CDR) global score of 0.5-1.0
Key exclusion criteria (4 listed)
- Age younger than 18 years
- CDR global score ≥2.0
- Severe upper-limb impairment, defined as MDS-UPDRS Part III finger-tapping item (3.4) score ≥3 in the dominant hand, or inability to produce more than 10 consecutive taps at ≥1 Hz despite instruction/practice
- Other neurological, musculoskeletal, or sensory conditions that preclude safe or reliable task participation
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 |
|---|---|---|
| Rhythmic Auditory CueingParticipants will perform finger-tapping tasks while listening to rhythmic auditory cues presented at three tempo conditions: preferred tempo, 20% slower, and 20% faster. Each cued condition will be repeated twice in randomized order. | Behavioural | Auditory-Cued Finger Tapping |
Primary outcome
Beta-band event-related desynchronization (β-ERD) during auditory-cued finger tapping
Time frame: Day 1, during each of six 2-minute auditory-cued finger-tapping trials
Beta-band event-related desynchronization (β-ERD; 13-30 Hz) will be derived from task-related EEG recorded during auditory-cued finger tapping. β-ERD is an EEG measure of sensorimotor activation and auditory-motor coupling during rhythmic movement. β-ERD will be compared across the three auditory cueing tempo conditions: preferred tempo, 20% slower than preferred tempo, and 20% faster than preferred tempo. Collected at a single study visit; during six 2-minute auditory-cued finger-tapping trials.
Inter-tap interval coefficient of variation (ITI-CV) during auditory-cued finger tapping
Time frame: Day 1, during each of six 2-minute auditory-cued finger-tapping trials
Inter-tap interval coefficient of variation (ITI-CV) will be calculated from the timing of consecutive finger taps during auditory-cued finger tapping. ITI-CV measures variability in tapping intervals and serves as an index of motor-timing precision and rhythmic consistency, with lower values indicating more consistent tapping. ITI-CV will be compared across the three auditory cueing tempo conditions: preferred tempo, 20% slower than preferred tempo, and 20% faster than preferred tempo. Collected at a single study visit; during six 2-minute auditory-cued finger-tapping trials.
3 secondary outcomes
EEG Alertness Index as assessed by theta/alpha ratio (TAR)
Time frame: Day 1, during each 2-minute eyes-open resting-state EEG recording collected between finger-tapping blocks
Participant-reported alertness as assessed by Visual Analogue Scale (VAS)
Time frame: Day 1, immediately after each of six 2-minute auditory-cued finger-tapping trials
Care-partner-reported participant alertness as assessed by Visual Analogue Scale (VAS)
Time frame: Day 1, immediately after each of six 2-minute auditory-cued finger-tapping trials
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 36333386Baik K, Jung JH, Jeong SH, Chung SJ, Yoo HS, Lee PH, Sohn YH, Kang SW, Ye BS. Implication of EEG theta/alpha and theta/beta ratio in Alzheimer's and Lewy body disease. Sci Rep. 2022 Nov 4;12(1):18706. doi: 10.1038/s41598-022-21951-5.
- Background: PubMed 36388209Pantelyat A, Dayanim G, Kang K, Turk B, Pagkatipunan R, Huenergard SK, Mears A, Bang J. Rhythmic auditory cueing in atypical parkinsonism: A pilot study. Front Neurol. 2022 Oct 28;13:1018206. doi: 10.3389/fneur.2022.1018206. eCollection 2022.
- Background: PubMed 29656189Stylianou M, Murphy N, Peraza LR, Graziadio S, Cromarty R, Killen A, O' Brien JT, Thomas AJ, LeBeau FEN, Taylor JP. Quantitative electroencephalography as a marker of cognitive fluctuations in dementia with Lewy bodies and an aid to differential diagnosis. Clin Neurophysiol. 2018 Jun;129(6):1209-1220. doi: 10.1016/j.clinph.2018.03.013. Epub 2018 Apr 3.
- Background: PubMed 37096339Donaghy PC, Carrarini C, Ferreira D, Habich A, Aarsland D, Babiloni C, Bayram E, Kane JP, Lewis SJ, Pilotto A, Thomas AJ, Bonanni L; Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment Lewy Body Dementias Prodromal Working Group. Research diagnostic criteria for mild cognitive impairment with Lewy bodies: A systematic review and meta-analysis. Alzheimers Dement. 2023 Jul;19(7):3186-3202. doi: 10.1002/alz.13105. Epub 2023 Apr 24.
- Background: PubMed 28592453McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7.
- Background: PubMed 34541289D'Antonio F, Kane JPM, Ibanez A, Lewis SJG, Camicioli R, Wang H, Yu Y, Zhang J, Ji Y, Borda MG, Kandadai RM, Babiloni C, Bonanni L, Ikeda M, Boeve BF, Leverenz JB, Aarsland D; ISTAART Lewy body dementias Consortia Working Group. Dementia with Lewy bodies research consortia: A global perspective from the ISTAART Lewy Body Dementias Professional Interest Area working group. Alzheimers Dement (Amst). 2021 Sep 14;13(1):e12235. doi: 10.1002/dad2.12235. eCollection 2021.
- Background: PubMed 25419243Rahimi J, Kovacs GG. Prevalence of mixed pathologies in the aging brain. Alzheimers Res Ther. 2014 Nov 21;6(9):82. doi: 10.1186/s13195-014-0082-1. eCollection 2014.
- Background: PubMed 28342649Mueller C, Ballard C, Corbett A, Aarsland D. The prognosis of dementia with Lewy bodies. Lancet Neurol. 2017 May;16(5):390-398. doi: 10.1016/S1474-4422(17)30074-1. Epub 2017 Mar 22.
- Individual participant dataSharing planned: No
Related trials for Dementia With Lewy Bodies (DLB)
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Recruiting
Transcranial Alternating Current Stimulation in Lewy Body Dementia
Lewy Body Dementia (LBD), Transcranial Alternating Current Stimulation
RecruitingPhase 2
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Cognitive Dysfunction, Lewy Body Disease
RecruitingPhase 2
Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
RecruitingPhase 3
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
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.
Kyurim Kang, PhD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Auditory Cueing in people with Dementia With Lewy Bodies (DLB) and Lewy Body Dementia (LBD), run by Johns Hopkins University.
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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyurim Kang, PhD (410-614-5671, kkang19@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-band event-related desynchronization (β-ERD) during auditory-cued finger tapping (time frame: Day 1, during each of six 2-minute auditory-cued finger-tapping trials). The study lists 2 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 NCT07846189, which also lists 8 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 9 Oct 2026.