An interventional study of BLT plus CBT and Sham BLT in Alzheimer Disease, Dementia and Brain Disorders, sponsored by Azienda Usl di Bologna. Completed at 1 site in Italy. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Azienda Usl di Bologna · Not applicable, Interventional, and Other
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.
The study presents three specific aims: 1) explore the potential alterations of mRCG cells in a population of DLB patients; 2) explore the efficacy of a multimodal intervention combining blue-enriched Bright Light Therapy (BLT) with Cognitive Behavioral Therapy (CBT); 3) explore changes in mRGCs system after BLT using a monochromatic light fMRI protocol. The study enrolled 40 patients with DLB, diagnosed according to established criteria and 40 age-matched controls. All participants underwent neurological, neuro-ophthalmological and neuropsychological assessments.
This proposal is based on three main hypotheses:
3,766 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's enrollment of 80 is above the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Azienda Usl di Bologna is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for patients:
Inclusion criteria for control entities:
Exclusion criteria for patients and control subjects:
To assess alterations of the mRGC system in a group of DLB patients (in comparison with a group of age-matched controls) and to explore the associations with specific clinical symptoms, such as visuospatial dysfunctions and sleep disorders.
Device: BLT plus CBT
Comparison age-matched controls group
Device: Sham BLT
For experimental group the intervention provided will be based on a bright light therapy combined with cognitive and behavioral tasks, BLT plus CBT
Patients in the active control group will only receive sham BLT.
mRGC-mediated pupillary light response
The integrated pupillometer Ganzfeld system (Espion V6, ColorDome Desktop Ganzfeld; Diagnosys LLC, Lowell, MA, USA) measured the pupil diameter (mm) at a 100 Hz sampling frequency. Participants (DLB and healthy controls) were dark-adapted for 10 min before undergoing the mRGC-condition, consisting of a 1-second high luminance blue flash (450 cd/m2 , 472 nm) delivered under dark-adapted conditions. Pupil diameter was recorded for 5 minutes during mRGC condition.
Time frame: Baseline
Change from T0 (baseline) to T1 in Cognitive composite score
The cognitive composite score is derived from 10 specific tests (MMSE Mini Mental State Examination, VOSP Visual Object and Space Perception battery , RAVLT Rey Auditory Verbal Learning Test, Digit Span Forward/Backward, Corsi Block-tapping, Phonemic/Semantic Fluency, Stroop Test, Rey-Osterrieth Complex Figure, and Judgment of Line Orientation), with higher scores reflecting better performance. To make tests with different metrics directly comparable, raw scores are converted into z-scores based on the baseline (T0) sample mean and standard deviation. The z-scores are averaged to form a single global cognitive score. This standardizes the scale and prevents any single test from having a disproportionate impact, giving equal weight to each test. The aim will be to determine if the change in this composite score from baseline (T0) to follow-up (T1) is significantly greater in the multimodal treatment group compared to the group receiving the sham treatment.
Time frame: At T0 (Baseline) and T1 (after 5 weeks of treatment)
fMRI protocol changes
Both DLB groups will undergo the same monochromatic fMRI protocol acquired at baseline to monitor changes in mRGCsmediated brain functional responses after treatment. fMRI acquisitions will take place within maximum 3 weeks after the lasttreatments session.
Time frame: 3 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Usl di Bologna