Study on Safety, Feasibility and Neural Activation of Non-Invasive Light Therapy System
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

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.
    

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.
    

Intervention name(s): Light Therapy System (LTS): Active setting; Light Therapy System (LTS): Sham setting
Intervention type(s): Other; Other
Intervention description(s): Exposure for 1 hour á day for consecutive days.; Exposure for 1 hour á day for consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Gamma entrainment; 40 Hz; Invisible Spectral Flicker; LED; Light Therapy; Brain stimulation; Gamma oscillations; Gamma induction