Evaluating How Red-light Therapy Applied to the Head Affects Symptoms, Daily Life, and Brain Activity in People With Dementia With Lewy Bodies

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity Hospital, Strasbourg, France

About this trial

Dementia with Lewy bodies (DLB) is a neurodegenerative disease diagnosed primarily based on the presence of cognitive decline, which may include difficulties with memory, attention, and more. Additionally, at least two of the following symptoms are needed for a probable diagnosis of DLB, and at least one for a possible DLB diagnosis (McKeith et al. 2017 and 2020):

* Fluctuations in cognition, attention, and/or alertness * Visual hallucinations * Spontaneous parkinsonism * REM sleep behavior disorder

Patients with DLB can experience cognitive deficits that can fluctuate and can vary for each patient. These may include deficits in memory, executive functions (planning and organizing), attention, visual processing, and language.

This study aims to evaluate the effect of red-light therapy, delivered using a helmet that contains small LED lights, in patients with DLB.

Participants' cognitive functions, clinical symptoms, quality of life and functional cerebral connectivity will be evaluated before starting therapy and again after three and six months of twice daily therapy use. As DLB also indirectly affects caregivers, the caregiver's quality of life and burden will also be evaluated before and at three and six months of therapy use by the participant.

The study's inclusion period is 24 months and the duration of participation for each patient is 8 months (+/-10 days) maximum.

Eligibility criteria

Qualifiers

Man or woman, 50 years or older

Probable DLB diagnosed according to the criteria of McKeith et al., 2017, or the criteria of McKeith et al., 2020 for prodromal DLB

Score on the Mini Mental State Examination (MMSE; Folstein et al., 1983) ≥ 18/30 at their last medical visit

Good mastery of the French language

Disqualifiers

Not able to understand the objectives and risks related to research and to give informed consent

Presence of another neurological disorder, including but not limited to brain tumors, stroke with potential cognitive impairment, or diagnosis of another progressive neurological disease (e.g., Alzheimer's disease, Parkinson's disease, etc.), and as determined by the investigator

Having an MMSE score < 18 at the screening visit

Unable to undergo a brain MRI due to medical reasons

Trial design

Treatments tested in this trial

  • LUCIOLE CAP
  • LUCIOLE CAP (sham version)

Treatment groups

40 Participants
are divided into 2 treatment groups