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Behavioural Intervention

Light Therapy for Alzheimer's Disease

N/A

Waitlist Available

Led By Priti Balchandani, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during waking hours for 26 weeks

Awards & highlights

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.

Who is the study for?

This trial is for people aged 50 and older with mild cognitive impairment or mild Alzheimer's disease, who have sleep disturbances. They must have had a PET scan showing amyloid protein in the past year and not live in long-term care facilities. Excluded are those with severe eye conditions, recent cataract surgery with certain lenses, on sleep meds, at risk of psychiatric hospitalization, or with other brain diseases.Check my eligibility

What is being tested?

The study tests whether light therapy can improve sleep and memory in patients by influencing their circadian rhythms—the body's natural 24-hour cycle affected by light. Participants will receive either the actual Lighting Intervention Therapy (LIT) or a sham version to compare effects.See study design

What are the potential side effects?

Potential side effects may include discomfort from exposure to light therapy such as eyestrain or headache. Since this is non-invasive treatment, serious side effects are unlikely but could involve worsening of sleep issues due to changes in light exposure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days/week for 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days/week for 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days/week for 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Brian Volumes

Changes in Perivascular Space Density

Secondary outcome measures

Changes Geriatric Depression Scale (GDS) Score

Changes in Dementia Quality of Life Instrument (DQoL) Score

Changes in Functional connectivity as measured by fMRI

+5 more

Trial Design

2Treatment groups

Active Control

Group I: Light Intervention Therapy (LIT) then Sham LITActive Control2 Interventions

The LIT will begin at the patient's home and will be presented for 10 weeks. A washout period of 1 month will be scheduled to diminish carryover effects of the first therapy arm, then patients will begin the Sham LIT.

Group II: Sham LIT then Light Intervention TherapyActive Control2 Interventions

LIT will be performed identical to Arm 1, except for switchover of active LIT and Sham. A washout period of 1 month will be scheduled to diminish carryover effects of the LIT arm.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

858 Previous Clinical Trials

524,261 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,668 Previous Clinical Trials

28,005,039 Total Patients Enrolled

Priti Balchandani, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Lighting Intervention Therapy (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05596994 — N/A

Alzheimer's Disease Research Study Groups: Light Intervention Therapy (LIT) then Sham LIT, Sham LIT then Light Intervention Therapy

Alzheimer's Disease Clinical Trial 2023: Lighting Intervention Therapy Highlights & Side Effects. Trial Name: NCT05596994 — N/A

Lighting Intervention Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05596994 — N/A

Frequently Asked Questions

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

Is senior citizens' participation encouraged in this investigation?

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

Answered by AI

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"

Answered by AI

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."

Answered by AI

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"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

7T MRI for Light Therapy in Patients With Mild Cognitive Impairment and Mild AD

Priti Balchandani 2023. "7T MRI for Light Therapy in Patients With Mild Cognitive Impairment and Mild AD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05596994.

All > Mild Cognitive Impairment