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NCT05260177

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

Recruiting now NA Last updated 24 January 2024
What this trial tests

NA trial testing Light Therapy System (LTS): Active Setting in Alzheimer's Disease in 62 participants. Currently enrolling.

Timeline
20 September 2022
Primary endpoint
30 May 2025
1 December 2026

Quick facts

Lead sponsorZealand University Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment62
Start date20 September 2022
Primary completion30 May 2025
Estimated completion1 December 2026
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Zealand University Hospital

Who can join

55 and older, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Audiovisual gamma stimulation for the treatment of neurodegeneration.
    Blanco-Duque C, Chan D, Kahn MC, Murdock MH, et al · · 2024 · cited 42× · PMID 38115692 · DOI 10.1111/joim.13755
  2. Proteostasis failure exacerbates neuronal circuit dysfunction and sleep impairments in Alzheimer's disease.
    Morrone CD, Raghuraman R, Hussaini SA, Yu WH. · · 2023 · cited 40× · PMID 37085942 · DOI 10.1186/s13024-023-00617-4
  3. Light-based gamma entrainment with novel invisible spectral flicker stimuli.
    Hansen LS, Carstensen MH, Henney MA, Nguyen NM, et al · · 2024 · cited 9× · PMID 39613776 · DOI 10.1038/s41598-024-75448-4
  4. Study on the effect of 40 Hz non-invasive light therapy system. A protocol for a randomized, double-blinded, placebo-controlled clinical trial.
    Agger MP, Horning M, Carstensen MS, Danielsen ER, et al · · 2023 · cited 5× · PMID 37901795 · DOI 10.3389/fnagi.2023.1250626
  5. Editorial: Recent advances in medical radiation technology.
    Acherar S. · · 2024 · cited 1× · PMID 38283564 · DOI 10.3389/fchem.2024.1360379
  6. Re-evaluating the choice of gamma stimulation frequency for the potential treatment of Alzheimer's disease: Novel invisible spectral flicker evokes gamma responses at various frequencies.
    Henney MA, Hansen BL, Hansen LS, Grønberg MG, et al · · 2025 · PMID 40392839 · DOI 10.1371/journal.pone.0321633
  7. Study on the Effect of 40 Hz Non-Invasive Light Therapy System. A Protocol for a Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.
    Agger MP, Horning MK, Carstensen MS, Danielsen ER, et al · · 2023 · DOI 10.21203/rs.3.rs-2571910/v1

Verify or expand the search:

Other recruiting trials for Alzheimer's Disease

Currently open trials in the same condition.

Other Zealand University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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