Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
ConditionMild Cognitive Impairment
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Circadian-Effective Light
DeviceNarrowband blue light
Rhythmic Light
Device40 hertz (Hz) flicker
Placebo Light
DeviceNarrowband red light
Placebo Rhythmic Light
DeviceRandom flicker for placebo rhythmic effect
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Active Intervention plus Active RhythmActive comparator 2 interventions
Group B: Active Light plus Placebo RhythmActive comparator 2 interventions
Group C: Placebo Light plus Active RhythmActive comparator 2 interventions
Group D: Placebo Light plus Placebo RhythmPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Cognition using the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Time frame
baseline2
Cognition using the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Time frame
at the end of week 93
Cognition using the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Time frame
at the end of week 14Secondary outcomes
1
Cognition using a working memory task
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Time frame
baseline2
Cognition using a working memory task
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Time frame
at the end of week 93
Cognition using a working memory task
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Time frame
at the end of week 144
Cognition using a word pair associates task
Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.
Time frame
baselineSponsors and contacts
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Source ClinicalTrials.gov