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Study on the Effect of 40 Hz Non-Invasive Light Therapy System

NCT05260177 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-05-07

No results posted yet for this study

Summary

The ALZLIGHT STAGE III Study is a continuation of the ALZLIGHT Pilot - Study on Safety, Feasibility and Neural Activation of Non-Invasive Light Therapy System. As with the first two stages, this study will examine whether entrainment of 40 Hz neural oscillation by novel 40 Hz Invisible Spectral Flicker is a potential therapy for Alzheimer's Disease. In order to examine this, 62 patients with mild to moderate Alzheimer's Disease will be recruited. The patients will be exposed to the Non-Invasive Light Therapy System for 1 hour a day for 6 months. The effect will be measured by a combination of electroencephalography, cognitive testing, functional magnetic resonance imaging, magnetic resonance spectroscopy and actigraphy.

Conditions

Interventions

DEVICE

Light Therapy System (LTS): Active Setting

Exposure for 1 hour á day for consecutive days

DEVICE

Light Therapy System (LTS): Sham Setting

Exposure for 1 hour á day for consecutive days

Sponsors & Collaborators

  • OptoCeutics

    collaborator INDUSTRY

  • University of Copenhagen

    collaborator OTHER

  • Technical University of Denmark

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Maibritt Horning, MSc · Zealand University Hospital, Department of Neurology

  • Mikkel Pejstrup Agger, MD · Zealand Univeristy Hospital, Department of Neurology

  • Peter Høgh, MD, Phd · Zealand Univeristy Hospital, Department of Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2028-12-01
Completion
2028-12-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260177 on ClinicalTrials.gov