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