Alzheimer's Disease, Mild Cognitive Impairment
Conditions
Brief summary
Investigate the long-term impact of amount and duration of Tailored Lighting Intervention (TLI) obtained from Aims 1 and 2 on sleep, cognition, circadian marker, mood, and behavior in AD/ADRD patients. For this single-arm, randomized, placebo-controlled study, the researchers plan to recruit 100 participants who will experience either the active TLI or the placebo for 6 months.
Interventions
The TLI will allow researchers to use a light source that will control how the circadian system is stimulated and provide the participants with options as to how the light treatment will be delivered.
The TLI will allow researchers to use a light source that will not stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.
Sponsors
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score \<25 * Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5
Exclusion criteria
* Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease * Obstructing cataracts * Severe macular degeneration * Use of sleep medication * Use of oral melatonin * untreated moderate to severe sleep apnea * Severe restless leg syndrome - Blindness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Disturbance using the Pittsburgh Sleep Quality Index (PSQI) | Up to Week 36 | The PSQI is used to measure sleep quality and is composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each subscale is scored 0 to 3. The sum of the 7 component scores yields a single global score with a full scale range of 0 to 21. A higher score indicates higher sleep disturbance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency using actigraphy | Up to Week 36 | Actigraphs will be worn continuously for 7 days during each assessment week. Changes in sleep efficiency will be measured using the actigraphy software. Sleep efficiency is a calculated as a ratio of the time spent in bed and the time spent sleeping |
| Depression using the Cornell Scale for Depression in Dementia (CSDD) | Up to Week 36 | The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. Full Scale ranges from 0 to 38 with a higher score indicating greater depression. |
| Agitation using the Cohen-Mansfield Agitation Inventory (CMAI) | Up to Week 36 | The CMAI assesses the frequency of manifestations of agitated behaviors in elderly persons. The CMAI is a caregivers' rating questionnaire consisting of 29 agitated behaviors, each rated on a 7-point scale of frequency. Score ranges from 30 to 210 with a higher score indicating higher agitated behavior. |
| Light measurements using the Daysimeter | Up to Week 36 | Circadian light measurements will be collected during waking hours for 7 days each assessment week using the daysimeter. The light measurement is reported as Lux levels. |
| Cognitive status Using the Montreal Cognitive Assessment (MOCA) | Up to Week 36 | The MoCA is a 1-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. Total score range from 0 to 30. Lower score indicates lower cognitive status. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMariana Figueiro, PhD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed