Study on the Effect of 40 Hz Non-Invasive Light Therapy System
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| ClinicalTrials.gov Identifier: NCT05260177 |
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Recruitment Status :
Recruiting
First Posted : March 2, 2022
Last Update Posted : December 14, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Device: Light Therapy System (LTS): Active Setting Device: Light Therapy System (LTS): Sham Setting | Not Applicable |
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 will last 8½ months for each participant and consist of 3 periods: Enrollment period of 1 month, an intervention period of 6 months, and a 1½ month post-interventional follow-up period.
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 62 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | A parallel-group randomized (1:1), double-blinded, placebo-controlled, clinical trial |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | Double-blinded |
| Primary Purpose: | Treatment |
| Official Title: | ALZLIGHT Stage III - Study on the Effect of 40 Hz Non-Invasive Light Therapy System |
| Actual Study Start Date : | September 20, 2022 |
| Estimated Primary Completion Date : | June 30, 2023 |
| Estimated Study Completion Date : | May 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Active
Exposure to LTS device set to 40 Hz invisible spectral flicker for 1 hour a day for consecutive days
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Device: Light Therapy System (LTS): Active Setting
Exposure for 1 hour á day for consecutive days |
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Sham Comparator: Sham
Exposure to LTS device set to continuous color matched white light for 1 hour a day for consecutive days
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Device: Light Therapy System (LTS): Sham Setting
Exposure for 1 hour á day for consecutive days |
- Gamma oscillations assessment [ Time Frame: Change from Baseline to 6 months and 7.5 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 and 7.5 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
- Cognition and memory assessment [ Time Frame: Change from Baseline to 6 months and 7.5 months ]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.
- Cognition and memory assessment [ Time Frame: Change from Baseline to 6 months and 7.5 months ]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.
- Cognition and memory assessment [ Time Frame: Change from Baseline to 6 months and 7.5 months ]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.
- Connectivity measures [ Time Frame: Change from Baseline to 6 months and 7.5 months ]rs-fMRI Connectivity: Estimate the temporal correlation between cortical regions, assess changes in correlation between cortical regions from baseline to 6 months and 7.5 months
- Connectivity measures [ Time Frame: Change from Baseline to 6 months and 7.5 months ]EEG Connectivity: Estimate the temporal correlation between cortical regions, assess changes in correlation between cortical regions from baseline to 6 months and 7.5 months
- MR Spectroscopy [ Time Frame: Change from Baseline to 6 months and 7.5 months ]MR Spectroscopy biomarkers: Assess changes from baseline to 6 months and 7.5 months
- Sleep Quality [ Time Frame: Change from Baseline to 6 months and 7.5 months ]
Assess changes from baseline to 6 months and 7.5 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
- Sleep Quality [ Time Frame: Change from Baseline to 6 months and 7.5 months ]
Assess changes from baseline to 6 months and 7.5 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
- Biomarkers of Alzheimer's Disease [ Time Frame: Change from Baseline to 6 months and 7.5 months ]Assess changes in biomarkers of Alzheimer's Disease in blood sampled from the participants from baseline to 6 months and 7.5 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).
- Safety Assessment [ Time Frame: 9 months ]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
- Feasibility assessment [ Time Frame: Baseline to 6 months ]
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
- Compliance assessment [ Time Frame: Baseline to 6 months ]
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
- MRI Atrophy assessment [ Time Frame: Change from Baseline to 6 months and 7.5 months ]Assess changes from baseline to 6 months and 7.5 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.
- MRI perfusion assessment [ Time Frame: Change from Baseline to 6 months and 7.5 months ]Assess MRI perfusion: Changes from baseline to 6 months and 7.5 months.
- EEG: Spectral feature assessment [ Time Frame: Change from Baseline to 6 months and 7.5 months ]Assess spectral features via rs-EEG Fourier power.
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| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Age > 55 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
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05260177
| Contact: Peter Høgh, MD, Phd | 47322809 | phh@regionsjaelland.dk | |
| Contact: Maibritt Horning, MSc | +45 81949649 | maibho@regionsjaelland.dk |
| Denmark | |
| Zealand University Hospital | Recruiting |
| Roskilde, Denmark, 4000 | |
| Contact: Peter Høgh, MD, Phd 47322809 phh@regionsjaelland.dk | |
| Contact: Maibritt Horning, MSc +4581949649 maibho@regionsjaelland.dk | |
| Principal Investigator: Peter Høgh, MD, Phd | |
| Sub-Investigator: Maibritt Horning, MSc | |
| Sub-Investigator: Mikkel Pejstrup Agger, MD | |
| Study Chair: | Maibritt Horning, MSc | Zealand University Hospital, Department of Neurology | |
| Study Chair: | Mikkel Pejstrup Agger, MD | Zealand Univeristy Hospital, Department of Neurology | |
| Principal Investigator: | Peter Høgh, MD, Phd | Zealand Univeristy Hospital, Department of Neurology |
Publications:
| Responsible Party: | Zealand University Hospital |
| ClinicalTrials.gov Identifier: | NCT05260177 |
| Other Study ID Numbers: |
ASIII |
| First Posted: | March 2, 2022 Key Record Dates |
| Last Update Posted: | December 14, 2022 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Gamma Entrainment 40 Hz Invisible Spectral Flicker LED |
Light Therapy Brain Stimulation Gamma Oscillations Gamma Induction |
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |