Trial Outcomes & Findings for Rhythmic Light Therapy for Alzheimer's Disease Patients (NCT NCT05015478)

Last Updated: 2024-12-03

Results Overview

Electroencephalography (EEG) recordings - the change in 40 Hz gamma power, computed by calculating the difference between the average gamma power at baseline (T1) and during the light intervention (T2). This difference was obtained by subtracting baseline 40 Hz power from the intervention 40 Hz power to assess acute neural effects

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

baseline and during the light intervention

Results posted on

2024-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Health Control Group 1 Healthy Control - Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting 1 hour intervention period where active lighting is experienced by participants. then 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants.	Health Control Group 2 Healthy Control - Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. then 1 hour intervention period where active lighting is experienced by participants.	Mild Cognitive Impairment Group 1 Mild Cognitive Impairment - Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting 1 hour intervention period where active lighting is experienced by participants. then 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants.	Mild Cognitive Impairment Group 2 Mild Cognitive Impairment - Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. then 1 hour intervention period where active lighting is experienced by participants.
Initial Experimental Condition STARTED	11	15	12	14
Initial Experimental Condition COMPLETED	11	15	12	14
Initial Experimental Condition NOT COMPLETED	0	0	0	0
Second Experimental Condition STARTED	11	15	12	14
Second Experimental Condition COMPLETED	11	15	12	13
Second Experimental Condition NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Health Control Group 1 Healthy Control - Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting 1 hour intervention period where active lighting is experienced by participants. then 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants.	Health Control Group 2 Healthy Control - Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. then 1 hour intervention period where active lighting is experienced by participants.	Mild Cognitive Impairment Group 1 Mild Cognitive Impairment - Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting 1 hour intervention period where active lighting is experienced by participants. then 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants.	Mild Cognitive Impairment Group 2 Mild Cognitive Impairment - Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. then 1 hour intervention period where active lighting is experienced by participants.
Second Experimental Condition Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Rhythmic Light Therapy for Alzheimer's Disease Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Health Control n=26 Participants Health Participants - 1 hour intervention period where active lighting is experienced by participants or 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants then in the second intervention experiences the opposite of the first intervention.	Mild Cognitive Impairment n=26 Participants Participants with Mild Cognitive Impairment - 1 hour intervention period where active lighting is experienced by participants or 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants then in the second intervention experiences the opposite of the first intervention.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and during the light intervention

Population: EEG data not collected for first 12 participants. Protocol revised to include EEG data collection subsequently.

Outcome measures

Outcome measures
Measure	MCI - Inactive Placebo Rhythmic Lighting n=10 Participants 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. Placebo Rhythmic Lighting Intervention: Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz). The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.	MCI - Active Tailored Rhythmic Lighting n=10 Participants 1 hour intervention period where active lighting is experienced by participants. Tailored Rhythmic Lighting Intervention: 40 hertz (Hz) rhythmic lighting (RL) for a duration of 1 hour. The flicker frequency of the 40 Hz RL will be 40 Hz and the stimulation will be a square wave with a 50 % duty cycle (i.e., 12.5 milliseconds light- on and 12.5 milliseconds light-off). The RL will provide a 30 lux of red light on a vertical plane at the eye level.	HC - Placebo Rhythmic Lighting n=10 Participants 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. Placebo Rhythmic Lighting Intervention: Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz). The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.	HC - Active Tailored Rhythmic Lighting n=10 Participants 1 hour intervention period where active lighting is experienced by participants. Tailored Rhythmic Lighting Intervention: 40 hertz (Hz) rhythmic lighting (RL) for a duration of 1 hour. The flicker frequency of the 40 Hz RL will be 40 Hz and the stimulation will be a square wave with a 50 % duty cycle (i.e., 12.5 milliseconds light- on and 12.5 milliseconds light-off). The RL will provide a 30 lux of red light on a vertical plane at the eye level.
Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) Oz	3.54 μV2/Hz Standard Deviation 0.43	5.28 μV2/Hz Standard Deviation 0.82	2.83 μV2/Hz Standard Deviation 0.53	4.10 μV2/Hz Standard Deviation 0.66
Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) Pz	2.69 μV2/Hz Standard Deviation 0.53	5.24 μV2/Hz Standard Deviation 0.94	3.86 μV2/Hz Standard Deviation 0.51	3.56 μV2/Hz Standard Deviation 0.55
Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) POz	2.87 μV2/Hz Standard Deviation 0.43	5.18 μV2/Hz Standard Deviation 0.88	3.29 μV2/Hz Standard Deviation 0.51	3.57 μV2/Hz Standard Deviation 0.64

SECONDARY outcome

Timeframe: Baseline and 1 hour after intervention (intervention is 2 hours)

Population: EEG data not collected for first 12 participants. Protocol revised to include EEG data collection subsequently. Outcome measure is comparing the two interventions Active Tailored Rhythmic Lighting vs Inactive Placebo Rhythmic Lighting regardless of cognitive status.

The Karolinska Sleepiness Scale (KSS) outcome prompts participants to rate how sleepy or alert they are feeling on a scale ranging from 1 to 9, where 1 = "very alert," 3 = "rather alert," 5 = "neither alert nor sleepy," 7 = "sleepy, but no difficulty remaining awake," and 9 = "very sleepy, fighting sleep, an effort to remain awake."

Outcome measures

Outcome measures
Measure	MCI - Inactive Placebo Rhythmic Lighting n=40 Participants 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. Placebo Rhythmic Lighting Intervention: Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz). The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.	MCI - Active Tailored Rhythmic Lighting n=40 Participants 1 hour intervention period where active lighting is experienced by participants. Tailored Rhythmic Lighting Intervention: 40 hertz (Hz) rhythmic lighting (RL) for a duration of 1 hour. The flicker frequency of the 40 Hz RL will be 40 Hz and the stimulation will be a square wave with a 50 % duty cycle (i.e., 12.5 milliseconds light- on and 12.5 milliseconds light-off). The RL will provide a 30 lux of red light on a vertical plane at the eye level.	HC - Placebo Rhythmic Lighting 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. Placebo Rhythmic Lighting Intervention: Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz). The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.	HC - Active Tailored Rhythmic Lighting 1 hour intervention period where active lighting is experienced by participants. Tailored Rhythmic Lighting Intervention: 40 hertz (Hz) rhythmic lighting (RL) for a duration of 1 hour. The flicker frequency of the 40 Hz RL will be 40 Hz and the stimulation will be a square wave with a 50 % duty cycle (i.e., 12.5 milliseconds light- on and 12.5 milliseconds light-off). The RL will provide a 30 lux of red light on a vertical plane at the eye level.
Mean Change in Subjective Sleepiness Using the Karolinska Sleepiness Scale (KSS)	0.44 score on a scale Standard Deviation 0	0.49 score on a scale Standard Deviation 0	—	—

SECONDARY outcome

Timeframe: 1 hour after intervention (intervention is 2 hours)

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). Performance is assessed in percent correct and by measuring accuracy and Reaction Time (RT).

Outcome measures

Outcome data not reported

Adverse Events

MCI - Active Tailored Rhythmic Lighting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MCI - Inactive Placebo Rhythmic Lighting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HC - Active Tailored Rhythmic Lighting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MC - Inactive Placebo Rhythmic Lighting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mariana Figueiro PhD

Icahn School Of Medicine at Mount Sinai

Phone: 212-241-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place