Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light \[RL\]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the circadian system and provides a 40 Hz flicker (RL); or (4) a light source that will stimulate the circadian system and provides a random flicker (placebo condition for rhythmic light). Following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks. After a 4-week washout period, a final round of assessments will be obtained. Study assessments (except for the Pittsburgh Sleep Quality Index and Montreal Cognitive Assessment) will be collected at the end of each week, for a total of 8 assessments.

Eligibility criteria

Qualifiers

Participants must be diagnosed with mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment score between 17 and 25;

Have sleep disturbance indicated by a score >5 on the Pittsburgh Sleep Quality Index

Participants must reside in their homes, independent living, or assisted living facilities

Disqualifiers

Participants taking sleep medication

Residence in a skilled nursing facility or long-term care

Obstructing cataracts, macular degeneration, and blindness

Severe sleep apnea or restless leg syndrome

Trial design

Treatments tested in this trial

  • Circadian-Effective Light
  • Rhythmic Light
  • Placebo Light
  • Placebo Rhythmic Light

Treatment groups

120 Participants
are divided into 4 treatment groups

Locations

2
Light and Health Research Center12204, MenandsNew York, United States
Icahn School of Medicine at Mount Sinai10029, New YorkNew York, United States

Sponsors and collaborators

Icahn School of Medicine at Mount Sinai

Lead sponsor