NCT07882251Completed
Shedding Light on Dementia With Lewy Bodies: a Multimodal 'Bright Light Treatment' to Modulate Brain Functions
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 25 Jul 2022
- Start date
- 16 Jun 2021
- Primary completion date
- 17 Apr 2025
- Lead sponsor
- Azienda Usl di Bologna
- Diseases
- Lewy body dementia, Alzheimer disease
- NCT number
- NCT07882251
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 16 Jun 2021 to the primary completion date, 17 Apr 2025
- 1 site in 1 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.
Prior treatment
- taking drugs that may contain the pupillary response;
- taking drugs that act on the central nervous system (anxiolytics, antidepressants, etc.);
Other illness
- ocular hypertension;
Other
- contraindications to performing MRI;
- have traveled through more than one time zone in the last 2 months;
- excessive daytime sleepiness as assessed by the Epworth Sleepiness Scale;
- presence of major depression assessed with the Beck Depression Inventory;
- retinal or optic nerve comorbidities including macular degeneration
Who the study is looking for
- diagnosis of DLB according to current criteria;
- age\> = 55 years;
- absence of contraindications to MRI;
- signature of the informed consent
- age\> = 55 years;
- absence of contraindications to MRI;
- absence of neurological pathologies;
- signature of the informed consent.
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Irccs - Istituto Delle Scienze Neurologiche Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.