Alzheimer's DiseaseNCT05260177
Study on the Effect of 40 Hz Non-Invasive Light Therapy System
A study testing Light Therapy System (LTS): Active Setting in people with Alzheimer's Disease, run by Zealand University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Light Therapy System (LTS): Active Setting
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Sep 2022to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult competent person, able to understand the nature of the study and give written informed consent.
- Diagnosed with probable mild to moderate AD based on NIA-AA diagnostic criteria or in a prodromal stage of AD with at least one positive biomarker of AD.
- Age > 40 years. Females must be post-menopausal.
- Fluent in Danish.
- > 8 years of normal school education
- Pass a color-blindness test (Ishihara color test)
- Have visual and auditory capabilities, and language skills necessary for neuropsychological testing.
- Participants must have a designated caregiver, who is available to the participant and can provide the necessary assistance with using the LTS device and the Actigraph wearable at home and assist with clinical visits and other practical issues
Who cannot join
- Profound visual impairment (visual acuity > 0.5) provided correction with spectacles, if needed
- Significant abnormalities related to important parts of the brain, e.g., the visual system, prefrontal cortex, or hippocampus, or relevant lesions detected by pre-trial imaging.
- Prior history of significant diseases related to the visual system or the brain.
- Medication: Use of any antiepileptic drugs, neuromodulating drugs or high dose of sedatives will be excluded.
- Prior history of substance abuse within the past 2 years.
- Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the PI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Roskilde, 4000
Peter Høgh, MD, Phd, 47322809, phh@regionsjaelland.dk
Maibritt Horning, MSc, +4581949649, maibho@regionsjaelland.dk
About this study
Official title: ALZLIGHT Stage III - Study on the Effect of 40 Hz Non-Invasive Light Therapy System
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.
Read the detailed description
Recent studies in mouse models of Alzhimer's Disease (AD) have shown that exposure to 40 Hz stroboscopic light therapy for one hour a day, resulted in slowing disease progression and lead to multiple neuroprotective effects such as cognition and memory recovery, and even scavenged both tau and Aβ protein species. Hence, the 40 Hz stroboscopic light therapy has a considerable potential for treatment of humans.
This study will utilize a novel way of masked light by alternating the spectral composition of a white light, rendering the flicker invisible to the conscience perception, while still entraining 40 Hz oscillations in the brain.
In the study, 62 patients with probable mild to moderate AD will be exposed to either invisible spectral flickering light through the Light Therapy System (LTS) (active setting) or continuous non-flickering white light (sham setting) for 1 hour each day. The sham setting is a high quality sham intervention as subjects will be blinded to the setting, both appear as white light.
The study participation will last 12 months for each participant and consist of 3 periods: An enrollment period, a randomized intervention period of 6 months, and 6 months of active intervention.
In order to test whether the LTS intervention is a potential treatment for AD, cognition will be measured by neuropsychological tests at baseline and at follow-ups. To get a better understanding of the potential effects, markers of efficacy based on MRI, MRS, EEG and blood samples will be tested.
The results from this study will increase the understanding of the impact of gamma oscillations in the human brain, and how it can be utilized as a novel and important tool for the treatment of neurodegenerative diseases.
- Conditions
- Alzheimer's Disease
- Being tested
- Light Therapy System (LTS): Active Setting, Light Therapy System (LTS): Sham Setting
- Keywords
- Gamma Entrainment, 40 Hz, Invisible Spectral Flicker, LED, Light Therapy, Brain Stimulation, Gamma Oscillations, Gamma Induction
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Therapy System (LTS): Active SettingDevice
Exposure for 1 hour á day for consecutive days
Light Therapy System (LTS): Sham SettingDevice
Exposure for 1 hour á day for consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Exposure to LTS device set to 40 Hz invisible spectral flicker for 1 hour a day for consecutive days Receives: Device: Light Therapy System (LTS): Active Setting |
| Sham | Sham comparator | Exposure to LTS device set to continuous color matched white light for 1 hour a day for consecutive days Receives: Device: Light Therapy System (LTS): Sham Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma oscillations assessment
Determine the total gamma power at 40 Hz, with no concomitant LTS device stimulation, assess changes in the gamma power at 40 Hz.
Measured: Change from Baseline to 6 months
Induction of 40 Hz Gamma oscillations
Estimate the change in electrical field patterns by EEG SSVEP, assess the difference between placebo and treatment for power spectral density signal to noise ratio at baseline measured by EEG SSVEP
Measured: Change from Baseline to 6 months
Secondary outcomes (15)
Cognition and memory assessment
Assess changes in cognition measured by the Alzheimer's Disease Assessment Scale -Cognitive Subscale plus Executive Functioning and Functional Ability (ADAS Cog plus EF \& FA). The score ranges from 0 to 135. A higher score reflects greater cognitive impairment.
Measured: Change from Baseline to 6 months and 12 months
Cognition and memory assessment
Assess changes in cognition measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL). The score ranges from 0 to 78. A higher score reflects a better outcome.
Measured: Change from Baseline to 6 months and 12 months
Cognition and memory assessment
Assess changes in cognition measured by the Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30. A higher score reflects a better outcome.
Measured: Change from Baseline to 6 months and 12 months
Connectivity measures
rs-fMRI Connectivity: Estimate the temporal correlation between cortical regions, assess changes in correlation between cortical regions from baseline to 6 months
Measured: Change from Baseline to 6 months
Connectivity measures
EEG Connectivity: Estimate the temporal correlation between cortical regions, assess changes in correlation between cortical regions from baseline to 6 months
Measured: Change from Baseline to 6 months
MR Spectroscopy
MR Spectroscopy biomarkers: Assess changes from baseline to 6 months
Measured: Change from Baseline to 6 months
Sleep Quality
Assess changes from baseline to 6 months of total sleep time in minutes, measured by actigraphy data and self-reported sleeping patterns (self-reported sleep quality scores based on patient's subjective report alone are often inaccurate).
Unit: total sleep time in minutes
Measured: Change from Baseline to 6 months
Sleep Quality
Assess changes from baseline to 6 months of wakefulness after sleep onset, measured in minutes of wakefulness after a patient has fallen asleep based on actigraphy data.
Unit: total time of wakefulness in minutes
Measured: Change from Baseline to 6 months
Biomarkers of Alzheimer's Disease
Assess changes in biomarkers of Alzheimer's Disease in blood sampled from the participants from baseline to 6 months. Markers of AD will be measured via ultrasensitive assays using fluid-based biomarkers such as plasma levels associated with amyloid pathology (plasma Aβ42/40 ratio), tau (plasma P-tau181 and P-tau231), neurodegeneration (plasma neurofilament light), and astrocytic function (glial fibrillary acidic protein).
Measured: Change from Baseline to 6 months
Safety Assessment
Estimate the safety of the LTS therapy, assess device- and procedure-related adverse events (DR/PR-AEs) including serious AEs (SAEs) occuring at any time during the trial
Measured: 12 months
Feasibility assessment
Investigate whether participants can meet the requirements of sitting in front of the LTS device for 1 hour per day. The feasibility of the LTS intervention will be measured by the amount of time (in minutes) of correct device use per day and through a self-report of usage via a compliance/feasibility questionnaire (structured interview on participant's self-reported usage and perception of the LTS device).
Unit: minutes per day of usage
Measured: Baseline to 6 months
Compliance assessment
Investigate the tolerability of the LTS intervention through questionnaires (structured interviews) measured by the number of protocol breaches in total, i.e., not complying with one hour of light stimulation per day during the intervention period, and qualitative assessment based on the compliance/feasibility questionnaire (structured interview on participant's self-reported usage and perception of the LTS device).
Unit: number of total protocol breaches
Measured: Baseline to 6 months
MRI Atrophy assessment
Assess changes from baseline to 6 months of global atrophy (ventricular volume and hippocampal volume) using advanced MR techniques on structural MRI data, i.e., including but not limited to voxel-based analysis.
Measured: Change from Baseline to 6 months
MRI perfusion assessment
Assess MRI perfusion: Changes from baseline to 6 months.
Measured: Change from Baseline to 6 months
EEG: Spectral feature assessment
Assess spectral features via rs-EEG Fourier power.
Measured: Change from Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start20 Sep 2022
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel-group randomized (1:1), double-blinded, placebo-controlled, clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- OptoCeutics, University of Copenhagen, Technical University of Denmark, Göteborg University
- Responsible party
- Sponsor
- Investigators
- Maibritt Horning, MSc, Study chair, Zealand University Hospital, Department of NeurologyMikkel Pejstrup Agger, MD, Study chair, Zealand Univeristy Hospital, Department of NeurologyPeter Høgh, MD, Phd, Principal investigator, Zealand Univeristy Hospital, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260177
- Sponsor's protocol ID
- ASIII
- Status last verified
- Aug 2025
- First submitted
- 26 Jan 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kasteleijn-Nolst Trenite D, Rubboli G, Hirsch E, Martins da Silva A, Seri S, Wilkins A, Parra J, Covanis A, Elia M, Capovilla G, Stephani U, Harding G. Methodology of photic stimulation revisited: updated European algorithm for visual stimulation in the EEG laboratory. Epilepsia. 2012 Jan;53(1):16-24. doi: 10.1111/j.1528-1167.2011.03319.x. Epub 2011 Nov 16.
PubMed 22091642Herrmann CS. Human EEG responses to 1-100 Hz flicker: resonance phenomena in visual cortex and their potential correlation to cognitive phenomena. Exp Brain Res. 2001 Apr;137(3-4):346-53. doi: 10.1007/s002210100682.
PubMed 11355381Martorell AJ, Paulson AL, Suk HJ, Abdurrob F, Drummond GT, Guan W, Young JZ, Kim DN, Kritskiy O, Barker SJ, Mangena V, Prince SM, Brown EN, Chung K, Boyden ES, Singer AC, Tsai LH. Multi-sensory Gamma Stimulation Ameliorates Alzheimer's-Associated Pathology and Improves Cognition. Cell. 2019 Apr 4;177(2):256-271.e22. doi: 10.1016/j.cell.2019.02.014. Epub 2019 Mar 14.
PubMed 30879788Iaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.
PubMed 27929004Adaikkan C, Tsai LH. Gamma Entrainment: Impact on Neurocircuits, Glia, and Therapeutic Opportunities. Trends Neurosci. 2020 Jan;43(1):24-41. doi: 10.1016/j.tins.2019.11.001. Epub 2019 Dec 10.
PubMed 31836315Adaikkan C, Middleton SJ, Marco A, Pao PC, Mathys H, Kim DN, Gao F, Young JZ, Suk HJ, Boyden ES, McHugh TJ, Tsai LH. Gamma Entrainment Binds Higher-Order Brain Regions and Offers Neuroprotection. Neuron. 2019 Jun 5;102(5):929-943.e8. doi: 10.1016/j.neuron.2019.04.011. Epub 2019 May 7.
PubMed 31076275Alawode DOT, Heslegrave AJ, Ashton NJ, Karikari TK, Simren J, Montoliu-Gaya L, Pannee J, O Connor A, Weston PSJ, Lantero-Rodriguez J, Keshavan A, Snellman A, Gobom J, Paterson RW, Schott JM, Blennow K, Fox NC, Zetterberg H. Transitioning from cerebrospinal fluid to blood tests to facilitate diagnosis and disease monitoring in Alzheimer's disease. J Intern Med. 2021 Sep;290(3):583-601. doi: 10.1111/joim.13332. Epub 2021 Jun 26.
PubMed 34021943Benedet AL, Mila-Aloma M, Vrillon A, Ashton NJ, Pascoal TA, Lussier F, Karikari TK, Hourregue C, Cognat E, Dumurgier J, Stevenson J, Rahmouni N, Pallen V, Poltronetti NM, Salvado G, Shekari M, Operto G, Gispert JD, Minguillon C, Fauria K, Kollmorgen G, Suridjan I, Zimmer ER, Zetterberg H, Molinuevo JL, Paquet C, Rosa-Neto P, Blennow K, Suarez-Calvet M; Translational Biomarkers in Aging and Dementia (TRIAD) study, Alzheimer's and Families (ALFA) study, and BioCogBank Paris Lariboisiere cohort. Differences Between Plasma and Cerebrospinal Fluid Glial Fibrillary Acidic Protein Levels Across the Alzheimer Disease Continuum. JAMA Neurol. 2021 Dec 1;78(12):1471-1483. doi: 10.1001/jamaneurol.2021.3671.
PubMed 34661615Agger MP, Horning M, Carstensen MS, Danielsen ER, Baandrup AO, Nguyen M, Hogh P, Miskowiak K, Petersen PM, Madsen KH, Kjaer TW. Study on the effect of 40 Hz non-invasive light therapy system. A protocol for a randomized, double-blinded, placebo-controlled clinical trial. Front Aging Neurosci. 2023 Oct 12;15:1250626. doi: 10.3389/fnagi.2023.1250626. eCollection 2023.
PubMed 37901795
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALZLIGHT Stage III - Study on the Effect of 40 Hz Non-Invasive Light Therapy System
- ClinicalTrials.gov ID
- NCT05260177
- Acronym / sponsor ID
- ASIII
- Conditions
- Alzheimer's Disease
- Keywords
- Gamma Entrainment, 40 Hz, Invisible Spectral Flicker, LED, Light Therapy, Brain Stimulation, Gamma Oscillations, Gamma Induction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- OptoCeutics, University of Copenhagen, Technical University of Denmark, Göteborg University
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recent studies in mouse models of Alzhimer's Disease (AD) have shown that exposure to 40 Hz stroboscopic light therapy for one hour a day, resulted in slowing disease progression and lead to multiple neuroprotective effects such as cognition and memory recovery, and even scavenged both tau and Aβ protein species. Hence, the 40 Hz stroboscopic light therapy has a considerable potential for treatment of humans.
This study will utilize a novel way of masked light by alternating the spectral composition of a white light, rendering the flicker invisible to the conscience perception, while still entraining 40 Hz oscillations in the brain.
In the study, 62 patients with probable mild to moderate AD will be exposed to either invisible spectral flickering light through the Light Therapy System (LTS) (active setting) or continuous non-flickering white light (sham setting) for 1 hour each day. The sham setting is a high quality sham intervention as subjects will be blinded to the setting, both appear as white light.
The study participation will last 12 months for each participant and consist of 3 periods: An enrollment period, a randomized intervention period of 6 months, and 6 months of active intervention.
In order to test whether the LTS intervention is a potential treatment for AD, cognition will be measured by neuropsychological tests at baseline and at follow-ups. To get a better understanding of the potential effects, markers of efficacy based on MRI, MRS, EEG and blood samples will be tested.
The results from this study will increase the understanding of the impact of gamma oscillations in the human brain, and how it can be utilized as a novel and important tool for the treatment of neurodegenerative diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel-group randomized (1:1), double-blinded, placebo-controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Light Therapy System (LTS): Active SettingExposure to LTS device set to 40 Hz invisible spectral flicker for 1 hour a day for consecutive days |
| Sham | Sham comparator | Device: Light Therapy System (LTS): Sham SettingExposure to LTS device set to continuous color matched white light for 1 hour a day for consecutive days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult competent person, able to understand the nature of the study and give written informed consent.
- Diagnosed with probable mild to moderate AD based on NIA-AA diagnostic criteria or in a prodromal stage of AD with at least one positive biomarker of AD.
- Age > 40 years. Females must be post-menopausal.
- Fluent in Danish.
- > 8 years of normal school education
Key exclusion criteria (6 listed)
- Profound visual impairment (visual acuity > 0.5) provided correction with spectacles, if needed
- Significant abnormalities related to important parts of the brain, e.g., the visual system, prefrontal cortex, or hippocampus, or relevant lesions detected by pre-trial imaging.
- Prior history of significant diseases related to the visual system or the brain.
- Medication: Use of any antiepileptic drugs, neuromodulating drugs or high dose of sedatives will be excluded.
- Prior history of substance abuse within the past 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light Therapy System (LTS): Active SettingExposure for 1 hour á day for consecutive days | Device | Active |
| Light Therapy System (LTS): Sham SettingExposure for 1 hour á day for consecutive days | Device | Sham |
Primary outcome
Gamma oscillations assessment
Time frame: Change from Baseline to 6 months
Determine the total gamma power at 40 Hz, with no concomitant LTS device stimulation, assess changes in the gamma power at 40 Hz.
Induction of 40 Hz Gamma oscillations
Time frame: Change from Baseline to 6 months
Estimate the change in electrical field patterns by EEG SSVEP, assess the difference between placebo and treatment for power spectral density signal to noise ratio at baseline measured by EEG SSVEP
15 secondary outcomes
Cognition and memory assessment
Time frame: Change from Baseline to 6 months and 12 months
Cognition and memory assessment
Time frame: Change from Baseline to 6 months and 12 months
Cognition and memory assessment
Time frame: Change from Baseline to 6 months and 12 months
Connectivity measures
Time frame: Change from Baseline to 6 months
Connectivity measures
Time frame: Change from Baseline to 6 months
MR Spectroscopy
Time frame: Change from Baseline to 6 months
Sleep Quality
Time frame: Change from Baseline to 6 months
Sleep Quality
Time frame: Change from Baseline to 6 months
Biomarkers of Alzheimer's Disease
Time frame: Change from Baseline to 6 months
Safety Assessment
Time frame: 12 months
Feasibility assessment
Time frame: Baseline to 6 months
Compliance assessment
Time frame: Baseline to 6 months
MRI Atrophy assessment
Time frame: Change from Baseline to 6 months
MRI perfusion assessment
Time frame: Change from Baseline to 6 months
EEG: Spectral feature assessment
Time frame: Change from Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 22091642Kasteleijn-Nolst Trenite D, Rubboli G, Hirsch E, Martins da Silva A, Seri S, Wilkins A, Parra J, Covanis A, Elia M, Capovilla G, Stephani U, Harding G. Methodology of photic stimulation revisited: updated European algorithm for visual stimulation in the EEG laboratory. Epilepsia. 2012 Jan;53(1):16-24. doi: 10.1111/j.1528-1167.2011.03319.x. Epub 2011 Nov 16.
- Background: PubMed 11355381Herrmann CS. Human EEG responses to 1-100 Hz flicker: resonance phenomena in visual cortex and their potential correlation to cognitive phenomena. Exp Brain Res. 2001 Apr;137(3-4):346-53. doi: 10.1007/s002210100682.
- Background: PubMed 30879788Martorell AJ, Paulson AL, Suk HJ, Abdurrob F, Drummond GT, Guan W, Young JZ, Kim DN, Kritskiy O, Barker SJ, Mangena V, Prince SM, Brown EN, Chung K, Boyden ES, Singer AC, Tsai LH. Multi-sensory Gamma Stimulation Ameliorates Alzheimer's-Associated Pathology and Improves Cognition. Cell. 2019 Apr 4;177(2):256-271.e22. doi: 10.1016/j.cell.2019.02.014. Epub 2019 Mar 14.
- Background: PubMed 27929004Iaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.
- Background: PubMed 31836315Adaikkan C, Tsai LH. Gamma Entrainment: Impact on Neurocircuits, Glia, and Therapeutic Opportunities. Trends Neurosci. 2020 Jan;43(1):24-41. doi: 10.1016/j.tins.2019.11.001. Epub 2019 Dec 10.
- Background: PubMed 31076275Adaikkan C, Middleton SJ, Marco A, Pao PC, Mathys H, Kim DN, Gao F, Young JZ, Suk HJ, Boyden ES, McHugh TJ, Tsai LH. Gamma Entrainment Binds Higher-Order Brain Regions and Offers Neuroprotection. Neuron. 2019 Jun 5;102(5):929-943.e8. doi: 10.1016/j.neuron.2019.04.011. Epub 2019 May 7.
- Background: PubMed 34021943Alawode DOT, Heslegrave AJ, Ashton NJ, Karikari TK, Simren J, Montoliu-Gaya L, Pannee J, O Connor A, Weston PSJ, Lantero-Rodriguez J, Keshavan A, Snellman A, Gobom J, Paterson RW, Schott JM, Blennow K, Fox NC, Zetterberg H. Transitioning from cerebrospinal fluid to blood tests to facilitate diagnosis and disease monitoring in Alzheimer's disease. J Intern Med. 2021 Sep;290(3):583-601. doi: 10.1111/joim.13332. Epub 2021 Jun 26.
- Background: PubMed 34661615Benedet AL, Mila-Aloma M, Vrillon A, Ashton NJ, Pascoal TA, Lussier F, Karikari TK, Hourregue C, Cognat E, Dumurgier J, Stevenson J, Rahmouni N, Pallen V, Poltronetti NM, Salvado G, Shekari M, Operto G, Gispert JD, Minguillon C, Fauria K, Kollmorgen G, Suridjan I, Zimmer ER, Zetterberg H, Molinuevo JL, Paquet C, Rosa-Neto P, Blennow K, Suarez-Calvet M; Translational Biomarkers in Aging and Dementia (TRIAD) study, Alzheimer's and Families (ALFA) study, and BioCogBank Paris Lariboisiere cohort. Differences Between Plasma and Cerebrospinal Fluid Glial Fibrillary Acidic Protein Levels Across the Alzheimer Disease Continuum. JAMA Neurol. 2021 Dec 1;78(12):1471-1483. doi: 10.1001/jamaneurol.2021.3671.
- Derived from this study: PubMed 37901795Agger MP, Horning M, Carstensen MS, Danielsen ER, Baandrup AO, Nguyen M, Hogh P, Miskowiak K, Petersen PM, Madsen KH, Kjaer TW. Study on the effect of 40 Hz non-invasive light therapy system. A protocol for a randomized, double-blinded, placebo-controlled clinical trial. Front Aging Neurosci. 2023 Oct 12;15:1250626. doi: 10.3389/fnagi.2023.1250626. eCollection 2023.
- Carstensen M et al. 40 Hz invisible spectral flicker and its potential use in Alzheimer's light therapy treatment. Proc. SPIE 11221, Mechanisms of Photobiomodulation Therapy XV, 112210L (11 March 2020)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maibritt Horning, MSc study chair
Zealand University Hospital, Department of Neurology
Mikkel Pejstrup Agger, MD study chair
Zealand Univeristy Hospital, Department of Neurology
Peter Høgh, MD, Phd principal investigator
Zealand Univeristy Hospital, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Therapy System (LTS): Active Setting in people with Alzheimer's Disease, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Høgh, MD, Phd (47322809, phh@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gamma oscillations assessment (time frame: Change from Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260177, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.