Alzheimer Disease, Mild Cognitive Impairment, Type2 Diabetes
Conditions
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.
Interventions
Lighting Intervention either Active or Placebo
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Participants will be randomly assigned to receive the active or placebo lighting condition
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic control | Done at Baseline, week 13 and 25 | Changes in glucose homeostasis and insulin sensitivity will be measured using the Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep disturbance | Done at Baseline, week 13, 25 and 48 | Change in sleep disturbance will be assessed using the Pittsburgh Sleep Quality Index. The sum of the 7 component scores yields a single global score. A person with a global score above 5 is considered to have sleep disturbances. A higher score indicates worsening sleep disturbance. |
| Depression | Done at Baseline, week 13, 25 and 48 | A change in depression will be assessed using the Geriatric Depression Scale |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMariana G Figueiro, PhD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed