Treatment for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Light and Health Research Center, Menands, NY
Alzheimer Disease+2 More
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a light therapy can improve sleep quality for people with insomnia.

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Eligible Conditions

  • Alzheimer Disease
  • Mild Cognitive Impairment (MCI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 9 secondary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of at the end of week 9..

Week 14
Cognition using a working memory task
Cognition using the Montreal Cognitive Assessment (MoCA)
Week 14
Cognition using a word pair associates task
Cognition using an implicit priming task
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Quality of Life using the Dementia Quality of Life Instrument
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
Week 9
Urine Melatonin Biomarker
week 14
Sleep Quantity using Actigraphy
week 14.
Light Exposure using a Daysimeter

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Active Intervention plus Active Rhythm
1 of 4
Placebo Light plus Active Rhythm
1 of 4
Active Light plus Placebo Rhythm
1 of 4
Placebo Light plus Placebo Rhythm
1 of 4
Active Control
Non-Treatment Group

This trial requires 120 total participants across 4 different treatment groups

This trial involves 4 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Active Intervention plus Active RhythmThe device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
Placebo Light plus Active RhythmThe device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
Placebo Light plus Placebo RhythmThe device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
Active Light plus Placebo RhythmThe device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 14
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 14 for reporting.

Who is running the study

Principal Investigator
M. F.
Prof. Mariana Figueiro, Professor, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai

Closest Location

Light and Health Research Center - Menands, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants must reside in their homes, independent living, or assisted living facilities
Sleep efficiency < 80% assessed by wearing an actigraph for 3 days
Participants must be diagnosed with amnestic 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

Patient Q&A Section

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Other questions from users

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

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Alzheimer Disease by sharing your contact details with the study coordinator.