Alzheimer DiseaseNCT07882251
Shedding Light on Dementia With Lewy Bodies: a Multimodal 'Bright Light Treatment' to Modulate Brain Functions
A study testing BLT plus CBT in people with Alzheimer Disease and Dementia, run by Azienda Usl di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia, Brain Disorders
- What is being tested?
- BLT plus CBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2021to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- contraindications to performing MRI;
- taking drugs that may contain the pupillary response;
- taking drugs that act on the central nervous system (anxiolytics, antidepressants, etc.);
- 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;
- ocular hypertension;
- retinal or optic nerve comorbidities including macular degeneration
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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:
- mRGC alterations in DLB: Patients with DLB are expected to show alterations of the melanopsin retinal ganglion cell (mRGC) system, similar to those reported in Alzheimer's disease and Parkinson's disease. Given the role of mRGCs in circadian and visual functions, these alterations may contribute to circadian and visuospatial disturbances in DLB. The mRGC system were evaluated using pupillometry to assess mRGC-mediated pupillary responses in DLB and healthy controls. Associations between mRGC alterations and clinical features of DLB were also be investigated.
- Effects of multimodal treatment: A multimodal intervention combining blue-enriched Bright Light Therapy (BLT) with Cognitive Behavioral Therapy (CBT) is hypothesized to be more effective than CBT alone in improving cognitive performance in DLB. Participants were randomly and blindly assigned to the experimental or active control group. Both groups received 15 one-hour sessions, three times per week for 5 weeks. Neuropsychological outcomes were assessed in both groups.
- mRGC-mediated brain responses: Monochromatic light stimulation during fMRI may provide a functional measure of mRGC-mediated brain responses and help characterize changes in the mRGC system following multimodal BLT plus CBT treatment. A longitudinal monochromatic fMRI protocol was performed at baseline and within 3 weeks after the final treatment session to investigate changes in mRGC-mediated brain functional responses following treatment in DLB.
- Conditions
- Alzheimer Disease, Dementia, Brain Disorders, Lewy Bodies Disease
- Being tested
- BLT plus CBT, Sham BLT
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLT plus CBTDevice
For experimental group the intervention provided will be based on a bright light therapy combined with cognitive and behavioral tasks, BLT plus CBT
Sham BLTDevice
Patients in the active control group will only receive sham BLT.
| Study group | Role | What they receive |
|---|---|---|
| DLB patients | Experimental | 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. Receives: Device: BLT plus CBT |
| Sham group | Sham comparator | Comparison age-matched controls group Receives: Device: Sham BLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start16 Jun 2021
- Primary completion17 Apr 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Micaela Mitolo, MD, PhD, Principal investigator, IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882251
- Sponsor's protocol ID
- GR-2019-12369242
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07882251
- Acronym / sponsor ID
- GR-2019-12369242
- Conditions
- Alzheimer Disease, Dementia, Brain Disorders, Lewy Bodies Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- mRGC alterations in DLB: Patients with DLB are expected to show alterations of the melanopsin retinal ganglion cell (mRGC) system, similar to those reported in Alzheimer's disease and Parkinson's disease. Given the role of mRGCs in circadian and visual functions, these alterations may contribute to circadian and visuospatial disturbances in DLB. The mRGC system were evaluated using pupillometry to assess mRGC-mediated pupillary responses in DLB and healthy controls. Associations between mRGC alterations and clinical features of DLB were also be investigated.
- Effects of multimodal treatment: A multimodal intervention combining blue-enriched Bright Light Therapy (BLT) with Cognitive Behavioral Therapy (CBT) is hypothesized to be more effective than CBT alone in improving cognitive performance in DLB. Participants were randomly and blindly assigned to the experimental or active control group. Both groups received 15 one-hour sessions, three times per week for 5 weeks. Neuropsychological outcomes were assessed in both groups.
- mRGC-mediated brain responses: Monochromatic light stimulation during fMRI may provide a functional measure of mRGC-mediated brain responses and help characterize changes in the mRGC system following multimodal BLT plus CBT treatment. A longitudinal monochromatic fMRI protocol was performed at baseline and within 3 weeks after the final treatment session to investigate changes in mRGC-mediated brain functional responses following treatment in DLB.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLB patients | Experimental | Device: BLT plus CBTTo 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. |
| Sham group | Sham comparator | Device: Sham BLTComparison age-matched controls group |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosis of DLB according to current criteria;
- age> = 55 years;
- absence of contraindications to MRI;
- signature of the informed consent
- age> = 55 years;
Key exclusion criteria (8 listed)
- contraindications to performing MRI;
- taking drugs that may contain the pupillary response;
- taking drugs that act on the central nervous system (anxiolytics, antidepressants, etc.);
- have traveled through more than one time zone in the last 2 months;
- excessive daytime sleepiness as assessed by the Epworth Sleepiness Scale;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLT plus CBTFor experimental group the intervention provided will be based on a bright light therapy combined with cognitive and behavioral tasks, BLT plus CBT | Device | DLB patients |
| Sham BLTPatients in the active control group will only receive sham BLT. | Device | Sham group |
Primary outcome
mRGC-mediated pupillary light response
Time frame: 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.
Change from T0 (baseline) to T1 in Cognitive composite score
Time frame: 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.
fMRI protocol changes
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micaela Mitolo, MD, PhD principal investigator
IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLT plus CBT in people with Alzheimer Disease and Dementia, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRGC-mediated pupillary light response (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.