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

December 12, 2022 updated by: Zealand University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Zealand
      • Roskilde, Region Zealand, Denmark, 4000
        • Zealand University DK34197393

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 1 week of intervention
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
After 1 week of intervention
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.
After 1 week of intervention
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.
After 6 weeks of intervention and subsequent 6 weeks of no intervention
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
After 6 weeks of intervention and subsequent 6 weeks of no intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Changes from baseline to 6 and 12 weeks
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
Changes from baseline to 6 and 12 weeks
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
Changes from baseline to 6 and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Changes from baseline to 6 and 12 weeks
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
Changes from baseline to 6 and 12 weeks
Stage II: Changes MR spectroscopy
Time Frame: Changes from baseline to 6 and 12 weeks
• Chance from baseline in brain metabolism at 6 weeks
Changes from baseline to 6 and 12 weeks
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
Changes from baseline to 6 and 12 weeks
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
Changes from baseline to 6 and 12 weeks
Stage II: Changes in Sleep Quality:
Time Frame: Changes from baseline to 6 and 12 weeks
• Actigraphy: To assess changes in sleep patterns
Changes from baseline to 6 and 12 weeks
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
Changes from baseline to 6 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

University of Copenhagen
Technical University of Denmark
OptoCeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

July 12, 2022

Study Completion (Actual)

July 12, 2022

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-085-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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