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Life sciences · Interventional Study
ClinicalTrials.gov · October 20, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07882251). This is a study registration, not published results. Lead sponsor: Azienda Usl di Bologna. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 80 participants (ACTUAL). Conditions: Alzheimer Disease, Dementia, Brain Disorders, Lewy Bodies Disease. Interventions: DEVICE: BLT plus CBT; DEVICE: Sham BLT. Primary outcome measures: mRGC-mediated pupillary light response , Baseline; Change from T0 (baseline) to T1 in Cognitive composite score , At T0 (Baseline) and T1 (after 5 weeks of treatment); fMRI protocol changes , 3 weeks. Brief summary: Dementia with Lewy Bodies (DLB) patients typically experience cognitive and behavioral dysfunctions that can be very distressing to both patients and caregivers, and extremely demanding for health care system. Despite these challenges and the relatively high prevalence of the disease, the evidence base for intervention strategies remains unclear. This project will aim to overcome this gap, showing for the first time in a DLB population, with a Randomized Controlled Trial (RCT), the feasibility and efficacy of a novel multimodal blue-enhanced Bright Light Treatment. Besides clinical outcomes, changes in melanopsin retinal ganglion cells (mRGCs) system will also be evaluated using a monochromatic light fMRI protocol. The results of this project will add valuable information to the current knowledge base of DLB for both scientific and clinical communities, helping clinicians in the prognosis and management of the disease, with the end goal of improving patients' quality of life.