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NCT05260177
Study on the Effect of 40 Hz Non-Invasive Light Therapy System
NA trial testing Light Therapy System (LTS): Active Setting in Alzheimer's Disease in 62 participants. Currently enrolling.
30 May 2025
Quick facts
| Lead sponsor | Zealand University Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 20 September 2022 |
| Primary completion | 30 May 2025 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Light Therapy System (LTS): Active Setting
- Light Therapy System (LTS): Sham Setting
Conditions studied
- Alzheimer's Disease — all drugs for Alzheimer's Disease →
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):
-
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 -
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 -
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 -
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 -
Editorial: Recent advances in medical radiation technology.
Acherar S. · · 2024 · cited 1× · PMID 38283564 · DOI 10.3389/fchem.2024.1360379 -
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 -
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:
- PubMed search for NCT05260177
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05260177 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zealand University Hospital
- Last refreshed: 24 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05260177.
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