Shedding Light on Dementia With Lewy Bodies: a Multimodal 'Bright Light Treatment' to Modulate Brain Functions
NCT07882251, Not applicable, Completed, Azienda Usl di Bologna
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Shedding Light on Dementia With Lewy Bodies: a Multimodal 'Bright Light Treatment' to Modulate Brain Functions | ClinicalTrials.gov |
| NCT number | NCT07882251 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Azienda Usl di Bologna | ClinicalTrials.gov |
| Conditions | Alzheimer Disease, Dementia, Brain Disorders, Lewy Bodies Disease | ClinicalTrials.gov |
| Interventions | BLT plus CBT, Sham BLT | ClinicalTrials.gov |
| First posted | 2026-10-20 | ClinicalTrials.gov |
| Last updated | 2026-10-20 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | mRGC-mediated pupillary light response | Baseline | 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. | ClinicalTrials.gov |
| Primary | Change from T0 (baseline) to T1 in Cognitive composite score | At T0 (Baseline) and T1 (after 5 weeks of treatment) | 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. | ClinicalTrials.gov |
| Primary | fMRI protocol changes | 3 weeks | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Primary outcome | ConductCognition |
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Corsi Block-Tapping Test | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Line Angle Matching | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)