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COMPLETED
NCT07882251
NA

Shedding Light on Dementia With Lewy Bodies: a Multimodal 'Bright Light Treatment' to Modulate Brain Functions

Sponsor: Azienda Usl di Bologna

View on ClinicalTrials.gov

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.

Official title: Shedding Light on Dementia With Lewy Bodies: a Randomized Controlled Trial Using a Multimodal 'Bright Light Treatment' to Modulate Brain Functional Responses Through the Eyes

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2021-06-16

Completion Date

2025-06-15

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

DEVICE

BLT plus CBT

For experimental group the intervention provided will be based on a bright light therapy combined with cognitive and behavioral tasks, BLT plus CBT

DEVICE

Sham BLT

Patients in the active control group will only receive sham BLT.

Locations (1)

Irccs - Istituto Delle Scienze Neurologiche

Bologna, Bologna, Italy