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Study on Safety, Feasibility and Neural Activation of Non-Invasive Light Therapy System (ALZLIGHT Pilot)

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ClinicalTrials.gov Identifier: NCT04574921
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
Technical University of Denmark
University of Copenhagen
OptoCeutics
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:

Induction of neural oscillations by flickering light is a well established method used for diagnostic of various neural diseases.

Recent studies in mice have shown promising results indicating that induction of gamma oscillation at 40 Hz leads to a reduction in amyloid-β and tau in mice models of Alzheimer's disease. This study will use flickering light to induce 40 Hz gamma oscillation as the previously mentioned studies.

In the study subject will be exposed to invisible spectral flickering light (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 appears as white light.

As this is the first trial, the focus will be on 1) safety of the intervention 2) feasibility of the proposed intervention time and method 3) indication of efficacy.

In stage 1 of the trial 4 age-matched subjects with no Alzheimer's disease will be recruited and be exposed for 1 week. In stage 2 10 patients with Alzheimer's disease will be recruited and exposed for 6 consecutive weeks.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: Light Therapy System (LTS): Active setting Other: Light Therapy System (LTS): Sham setting Not Applicable

Detailed Description:

Induction of neural oscillations by flickering light is a well established method used for diagnostic of various neural diseases (5,6).

Recent studies in mice have shown promising results indicating that induction of gamma oscillation at 40 Hz leads to a reduction in amyloid-β an tau in mice models of Alzheimer's disease (1-4). This study will use flickering light to induce 40 Hz gamma oscillation as the previously mentioned studies.

This study will utilize a novel way of masking the 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 subject will be exposed to invisible spectral flickering light (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 appears as white light.

As this is the first trial, the focus will be on 1) safety of the intervention 2) feasibility of the proposed intervention time and method 3) indication of efficacy.

In stage 1 of the trial 4 age-matched subjects with no Alzheimer's disease will be recruited and be exposed for 1 week. In stage 2 10 patients with Alzheimer's disease will be recruited and exposed for 6 consecutive weeks. Following the 6 weeks of intervention the subject will have 6 weeks of no intevention and assesed agian.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: ALZLIGHT Pilot: Study on Safety, Feasibility and Neural Activation of Non-Invasive Light Therapy System
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
Exposure to LTS device set to 40 Hz invisible spectral flicker for 1 hour a day for consecutive days
Other: Light Therapy System (LTS): Active setting
Exposure for 1 hour á day for consecutive days.

Sham Comparator: Sham
Exposure to LTS device set to continues color matched white light for 1 hour a day for consecutive days
Other: Light Therapy System (LTS): Sham setting
Exposure for 1 hour á day for consecutive days.




Primary Outcome Measures :
  1. Stage I: Feasibility / Compliance assesment [ Time Frame: After 1 week of intervention ]
    • The compliance of the LTS intervention will be measured by the amount of time (in minutes) of device use per day.

  2. Stage I: Usability Assessment: [ Time Frame: After 1 week of intervention ]
    • Usability report on use of device during intervention in the subject's home based on device speciffic questionnaire / structured interviews

  3. Stage I: Safety Assessment. Evaluation of Adverse Events related to the LTS intervention. [ Time Frame: After 1 week of intervention ]
    • Safety assessment will be done by collection of all types of adverse events and categorization into severity and relationship to LTS treatment.

  4. Stage II: Feasibility / Compliance assesment [ Time Frame: After 6 weeks of intervention and subsequent 6 weeks of no intervention ]
    • The compliance of the LTS intervention will be measured by the amount of time (in minutes) of device use per day.

  5. Stage II: Safety Assessment. Evaluation of Adverse Events related to the LTS intervention. [ Time Frame: After 6 weeks of intervention and subsequent 6 weeks of no intervention ]
    • Device- and procedure-related adverse events (DR/PR-AEs) including serious AEs (SAEs) occurring at any time during the trial


Secondary Outcome Measures :
  1. Stage II: Induction of gamma ocsillations [ Time Frame: Changes from baseline to 6 and 12 weeks ]
    • The effect of the LTS intervention will be measured by the amount of 40 Hz SSVEP response during treatment

  2. Stage II: Connectivity meassures in resting-state functional MRI [ Time Frame: Changes from baseline to 6 and 12 weeks ]
    • rs-fMRI Connectivity: Change from baseline in correlations between cortical regions at 6 weeks

  3. Stage II: Connectivity meassures in EEG [ Time Frame: Changes from baseline to 6 and 12 weeks ]
    • EEG Connectivity: Change from baseline in correlations between cortical regions at 6 weeks


Other Outcome Measures:
  1. Stage II: Changes in cognition: [ Time Frame: Changes from baseline to 6 and 12 weeks ]
    • Changes in cognition meassured by the ADAS Cog Plus EF & FA neuropsychological test. Score from 0 to 200

  2. Stage II: Changes in cognition: [ Time Frame: Changes from baseline to 6 and 12 weeks ]
    • Changes in cognition meassured by the Trailmaking A&B score from 0 to 1200 seconds

  3. Stage II: Changes MR spectroscopy [ Time Frame: Changes from baseline to 6 and 12 weeks ]
    • Chance from baseline in brain metabolism at 6 weeks

  4. Stage II: Changes MR Perfusion [ Time Frame: Changes from baseline to 6 and 12 weeks ]
    • Chance from baseline in perfusion meassured by Arterial Spin Labelling at 6 weeks

  5. Stage II: Changes MR volumemetry [ Time Frame: Changes from baseline to 6 and 12 weeks ]
    • Chance from baseline in structural volume of neural structures at 6 weeks

  6. Stage II: Changes in Sleep Quality: [ Time Frame: Changes from baseline to 6 and 12 weeks ]
    • Actigraphy: To assess changes in sleep patterns

  7. Stage II: EEG spectral features: [ Time Frame: Changes from baseline to 6 and 12 weeks ]
    • rs-EEG fourier power: To assess changes in spectral features



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult competent persons able to understand the nature of the study and give written informed consent.
  • Stage I: Healthy elderly subject.
  • Stage II: Diagnosed with probable mild to moderate AD based on NIA-AA diagnostic criteria.
  • Age >55 years and <80 years. Females must be post-menopausal.
  • Fluent in Danish
  • > 8 year of normal school education
  • Pass a colour-blindness test (Ishihara colour test)
  • Have visual and auditory capabilities, and language skills necessary for neuropsychological testing.
  • Furthermore, subjects must have a person, hereafter named designated caregiver, who is available to the participant and can provide the necessary assistance with using the LTS device and Actigraph wearable at home and can assist with clinic visits and other practical issues.

Exclusion Criteria:

  • Profound visual impairment provided correction with spectacles, if needed.
  • Significant abnormalities related to important parts of the brain e.g. the visual system, pre-frontal cortex or hippocampus, or relevant lesions detected by MRI.
  • Prior history of significant diseases related to the visual system or the brain.
  • Medication Any patient using 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.

Information from the National Library of Medicine

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): NCT04574921


Contacts
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Contact: Troels Wesenberg Kjær, MD, Phd +4546323200 twk@regionsjaelland.dk
Contact: Mikkel Agger, MD +45447322976 magge@regionsjaelland.dk

Sponsors and Collaborators
Zealand University Hospital
Technical University of Denmark
University of Copenhagen
OptoCeutics
Additional Information:
Publications:

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT04574921    
Other Study ID Numbers: REG-085-2020
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
Gamma entrainment
40 Hz
Invisible Spectral Flicker
LED
Light Therapy
Brain stimulation
Gamma oscillations
Gamma induction
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders