Clinical trial NCT03933696: Light, Metabolic Syndrome and Alzheimer's Disease - Aim 2
Official title: Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Type2 Diabetes
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 23
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to receive the active or placebo lighting condition
Primary purpose: TREATMENT

Brief summary: To test the long term effect of a light treatment on cognition, sleep and metabolism in patients with Mild cognitive impairment (MCI) or mild Alzheimer's disease or related dementia (ADRD).

Detailed description: Test if a tailored light intervention (TLI) that promotes entrainment can improve sleep disturbances, inflammation, insulin sensitivity (Si) and glucose disposal (Sg) and cognition in patients with MCI and mild ADRD and sleep disturbances. Using a single-arm, between-subjects, placebo-controlled study the investigators will investigate if long-term (6-month) exposure to TLI improves glucose homeostasis and insulin sensitivity in patients with MCI and mild AD who suffer from sleep disturbance and are living at home. Participants will be recruited from the Mount Sinai AD research center (ADRC) and randomized to receive the TLI (or comparison control treatment) at home. The investigators hypothesize that, compared to the comparison light, a TLI will increase entrainment, improve sleep, reduce depression, reduce inflammation, improve metabolic control, increase insulin sensitivity, and reduce susceptibility to T2DM and metabolic disease during and after the completion of the 6-month intervention.

Eligibility criteria: Inclusion Criteria:

* Mild cognitive impairment
* Mild Alzheimer's Disease
* Sleep Disturbance
* Live at home

Exclusion Criteria:

* Blindness
* insulin-dependent diabetes patients
* macular degeneration
* severe sleep apnea

Primary outcomes:
measure: Sleep disturbance
timeFrame: Done at Baseline, week 13, 25 and 48
measure: Metabolic control
timeFrame: Done at Baseline, week 13 and 25
measure: Depression
timeFrame: Done at Baseline, week 13, 25 and 48
measure: Cognition
timeFrame: Done at Baseline, week 13, 25 and 48
measure: Cognition
timeFrame: Done at Baseline, week 13, 25 and 48
Secondary outcomes:
measure: Sleep disturbance using actigraphy
timeFrame: Done at Baseline, week 13, 25 and 48
measure: Light measurements
timeFrame: Done at Baseline, week 13, 25 and 48
measure: Melatonin Levels
timeFrame: One morning during Baseline, week 13, 25 and 48
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mariana G Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: