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Light helmet for Alzheimer's shows promise, but study cut short

NCT ID NCT03672474

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a special helmet and abdominal panel that shines near-infrared light and uses a static magnetic field on people with mild-to-moderate Alzheimer's disease. The goal was to see if it could safely improve memory and thinking. The study planned to enroll 60 participants but was terminated early, so we don't have full results.

What this could mean

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

Active substance
Photobiomodulation device (helmet and abdominal panel with near-infrared lasers, LEDs, and static magnetic field)
What this could lead to
If it works, this could point toward a non-drug way to slow cognitive decline in Alzheimer's patients.
What could go wrong
The study was terminated early, so we don't have clear results. It was a small pilot trial, and previous anti-amyloid approaches have failed, so success is uncertain.

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

60 people

The number who actually took part.

Started

Sep 2018

Finished

May 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

55 to 85 years

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: * Male and/or Female ; * Age between 55-85 years old ; * Diagnostic of AD according to international criteria of McKhann et al., 2011 \[1\] ; * Mild-to-moderate Alzheimer's disease stage with MMSE score between 16 and 26 ; * Symptomatic treatments specific to AD (Memantine, acetylcholinesterase inhibitors) and pyshotropic treatments (anxiolytics, anti-depressants, neuroleptics) are allowed but must be maintained at fixed doses during the 4 weeks previous to inclusion and during all the study length ; * Patient approval for biological, eletrophysiological and imaging tests ; * Enough availability to participate daily to the proposed treatment sessions ; * Given informed, free consent, written and signed by participant and investigator (at the latest on the day of inclusion and before any examination needed for the research) ; * Affiliated to social security regime or beneficiary of such a regime ; * Patient given approval to perform a second lumbar puncture (without contraindication) if tests results and/or neurological follow-up need a CSF test for biomarkers ; Exclusion Criteria: * Exclusion criteria: * Clinical and paraclinical details insufficient for AD diagnostic ; * Genetic form of AD (genetic mutation characterized) ; * No caregiver to complete neuropsychological scales and evaluation forms ; * Patient living in a medical institution ; * Illiteracy or inability to perform psycho-behavioral tests ; * Physical or neurosensory problems susceptible to interfere with tests * Contraindication or refusal to perform MRI imagerie examinations, PET-FDG, P300 and/or actimetry tests ; * Patient carrying a pacemaker device or a ferromagnetic compound ; * Short-term life-threatening pathologies (evolutive cancer, unstable cardiac failure, liver or kidney failure, severe respiratory insufficiency) ; * Chronic psychosis or psychotic episodes ; * Alcohol or drug addiction ; * Epilpesy or other non-neurodegenerative diseases of the central nervous system ; * Deficits in B12 and non-supplemented folic acid levels ; * Untreated hypothyroidism ; * Major skin lesions on treatment application regions (possibility to apply a bandage during the treatment if minor lesions) ; * Recent major chirurgical intervention at the abdomen in the past three month before inclusion ;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Montpellier University Hospital, Gui de Chauliac

    Montpellier, 34295, France

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Other studies related to the condition(s) this trial covers.