Light Intervention Therapy (LIT) then Sham LIT for Mild Cognitive Impairment

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NYMild Cognitive Impairment+1 MoreLighting Intervention Therapy - Device
Eligibility
50 - 85
All Sexes
What conditions do you have?
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Study Summary

This trial will investigate the effect of a light treatment on sleep, memory and brain function in people with MCI and Alzheimer's. Light treatment may improve sleep and memory in these patients.

Eligible Conditions
  • Mild Cognitive Impairment
  • Alzheimer's Disease

Treatment Effectiveness

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: During waking hours for 26 weeks

Week 26
Percentage of Time Spent in Bed Sleeping
Week 10
Changes Geriatric Depression Scale (GDS) Score
Changes in Dementia Quality of Life Instrument (DQoL) Score
Changes in Montreal Cognitive Assessment (MoCA) Score
Week 4
Pittsburgh Sleep Quality Index (PSQI) Score
Week 26
Changes in Brian Volumes
Changes in Functional connectivity as measured by fMRI
Changes in Perivascular Space Density
Changes in Structural connectivity as measured by dMRI
Week 26
Circadian Stimulus (CS) values using the Daysimeter

Trial Safety

Trial Design

2 Treatment Groups

Light Intervention Therapy (LIT) then Sham LIT
1 of 2
Sham LIT then Light Intervention Therapy
1 of 2

Active Control

25 Total Participants · 2 Treatment Groups

Primary Treatment: Light Intervention Therapy (LIT) then Sham LIT · No Placebo Group · N/A

Light Intervention Therapy (LIT) then Sham LITActiveComparator Group · 2 Interventions: Lighting Intervention Therapy, Sham LIT · Intervention Types: Device, Device
Sham LIT then Light Intervention TherapyActiveComparator Group · 2 Interventions: Lighting Intervention Therapy, Sham LIT · Intervention Types: Device, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: during waking hours for 26 weeks

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
791 Previous Clinical Trials
508,959 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,450 Previous Clinical Trials
4,279,552 Total Patients Enrolled
Priti Balchandani, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Mariana Figueiro, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
7 Previous Clinical Trials
738 Total Patients Enrolled

Eligibility Criteria

Age 50 - 85 · All Participants · 5 Total Inclusion Criteria

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You're allowed to take antidepressants, but we need to keep track of the type and amount you're taking.

Frequently Asked Questions

Is senior citizens' participation encouraged in this investigation?

"Patients between 50 to 85 years of age are eligible for this clinical trial." - Anonymous Online Contributor

Unverified Answer

Which individuals are qualified to join this investigation?

"This trial is recruiting 25 adults aged between 50 and 85 who have been diagnosed with mild cognitive impairment (MCI). Besides this, they must also be amyloid beta positive according to a prior PET scan, not taking any antidepressant medications or those on antidepressants should report the drugs taken as well as dosages. Furthermore, participants need to fall in-between 0.5-4.0 and 4.5-9.0 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB), suffer from circadian sleep disturbances while residing at home, independent living or assisted living facilities" - Anonymous Online Contributor

Unverified Answer

How many participants are involved in this experiment?

"Yes, the data hosted on clinicaltrials.gov confirms that this trial is enrolling participants. The post was published on November 1st 2022 and recently edited October 25th 2022. There are 25 openings at a single site." - Anonymous Online Contributor

Unverified Answer

What is the primary aim of this research project?

"This trial seeks to evaluate Changes in Brain Volumes over a Baseline and post-therapy time frame at Week 26. Secondary outcomes include Pittsburgh Sleep Quality Index (PSQI) Score, Circadian Stimulus (CS) values utilizing the Daysimeter device, and changes in Montreal Cognitive Assessment (MoCA) Score. The PSQI is a self-rated 19 item survey that gauges sleep quality on an interval scale of 0-3 with higher scores indicating poorer sleeping habits; The MoCA is a one page 30 point test that measures short term memory, executive functions, attention etc., it has been validated as an effective tool" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.