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NCT07846189Not yet recruiting

Rhythmic Entrainment and Alertness in Lewy Body Dementia

Rhythmic Entrainment and Alertness Co-modulating Test in Dementia With Lewy Bodies (REACT-DLB): Pilot Study

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
18 Sept 2026
Start date
30 Nov 2026
Primary completion date
31 Jul 2027
Lead sponsor
Johns Hopkins University
NCT number
NCT07846189

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 30 Nov 2026 to the primary completion date, 31 Jul 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Age

  • Age younger than 18 years

Other

  • CDR global score ≥2.0

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.