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

Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests flickering light and light that affects the body's daily clock in people with mild memory and thinking problems or mild Alzheimer's disease who also have sleep problems. People are placed by chance into one of four light groups and use their assigned light for 2 hours each morning for 8 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have mild cognitive impairment (mild memory and thinking problems) or mild Alzheimer's disease, with a score of 17 to 25 on the Montreal Cognitive Assessment.
  • Have sleep problems, with a score above 5 on the Pittsburgh Sleep Quality Index.
  • Live at home, in independent living, or in assisted living.

Who can't join

  • Take sleep medicine.
  • Live in a skilled nursing facility or long-term care.
  • Have cataracts that block vision, macular degeneration (damage to the part of the eye used for central vision), or blindness.
  • Have severe sleep apnea (breathing that stops and starts during sleep) or restless leg syndrome (a strong urge to move the legs).
  • Have a history of severe epilepsy, a condition that causes seizures.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * History of severe epilepsy

Study sites (2)

NY