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Can Blue-Enhanced light rewire brain responses in lewy body dementia?

NCT ID NCT07882251

Symptom relief Sponsor: Azienda Usl di Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time

Summary

Researchers are testing a bright light treatment combined with cognitive and behavioral tasks in people with dementia with Lewy bodies, a condition that causes distressing changes in thinking and behavior. The trial enrolls about 80 participants aged 55 and older, including healthy controls, and compares the active treatment with a sham light session. The team will measure changes in pupil responses, a composite score from ten cognitive tests, and brain activity using functional MRI to see whether the light-based approach affects brain function through the eyes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bright light therapy combined with cognitive and behavioral tasks
What this could lead to
If it works, bright light therapy could offer a low-risk way to ease cognitive and behavioral symptoms in dementia with Lewy bodies and give clinicians a new management option.
What could go wrong
This is a small, early-stage trial, so any benefits may not hold up in larger studies or translate into meaningful daily-life improvements. Light therapy can also disrupt sleep or trigger eye discomfort in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

Jun 2021

Finished

Jun 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria for patients: * diagnosis of DLB according to current criteria; * age\> = 55 years; * absence of contraindications to MRI; * signature of the informed consent Inclusion criteria for control entities: * age\> = 55 years; * absence of contraindications to MRI; * absence of neurological pathologies; * signature of the informed consent. Exclusion criteria for patients and control subjects: * 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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease brain disorder dementia Lewy body dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Brain disorders Dementia Lewy bodies disease

Contacts and locations

Locations

  • Irccs - Istituto Delle Scienze Neurologiche

    Bologna, Bologna, 40139, Italy

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