The Healthy Patterns Study

Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and
fatal neurodegenerative condition, affecting close to 15 million family caregivers (CG).
Circadian rhythm disorders (CRDs) occur in the majority of persons with dementia and include
late afternoon/evening agitation (e.g. sundowning) and irregular sleep-wake rhythms such as
daytime hypersomnia, frequent night awakenings, and poor sleep efficiency. CRDs can cause a
specific cluster of neuropsychiatric symptoms that occur in over 60 percent of patients with
dementia and are associated with increased morbidity and mortality and decreased quality of
life. Regulating the circadian system via different types of activity have been shown to
alter core clock processes that drive CRD symptoms and suggests that a combination of
cognitive, physical, and sensory-based activities, delivered at strategic times, may be an
effective mechanism to reduce neuropsychiatric symptoms, decrease sleep disruptions, and
enhance quality of life for both the care receiver and the caregiver.

Specific components of this brief, one-month, eight sessions, home-based intervention
include: 1) assessing PWD health/functional status and preferences/interests; 2) educating
caregivers on environmental cues to promote activity and sleep; and 3) training of caregivers
in using timed morning, afternoon, and evening activities based on circadian needs across the
day.

Inclusion criteria for care receiver (CR):

1. be over age 60

2. English speaking

3. be able to tolerate wrist actigraphy (wear a watch on their wrist for a month)

4. diagnosed with dementia using standard assessments and diagnostic criteria

5. has CG reporting the presence of CRD symptoms

6. If the CR is on any of four classes of psychotropic medications (antidepressant,
benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication
(memantine or a cholinesterase inhibitor), we will require that the CR have been on a
stable dose for 90 days prior to enrollment (typical time frame in clinical trials) to
minimize possible confounding effects of concomitant medications

Inclusion criteria for caregiver (CG):

1. CG is at least 18 years old

2. CG lives close to the participant

3. CG is planning to live in the area for at least 6 months

4. If CG is on a psychotropic medication, CG must be on a stable dose for at least 60
days

Exclusion criteria for CR:

1. deemed to be in a crisis/unsafe situation at baseline

2. reported planned transition to another residential or care setting in less than 6
months

3. at end-stage disease (defined as bed-bound and noncommunicative, or on hospice at
baseline)

4. currently enrolled in an interventional clinical trial for dementia or associated
symptoms

5. regular use of medications with substantial known effects on the measurement of HPA
activity (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy)

6. major surgery in the past 3 months

7. history of major psychiatric and/or personality disorder

8. history of heavy cigarette smoking (e.g. than 50 pack years)

9. loss of a loved one in the past 3 months

10. conditions known to affect measurement of circadian rhythm such as use of sedatives/
hypnotics, Huntington's disease, Cushing's disease, Addison's disease, normal pressure
hydrocephalus, Parkinson's disease, advanced heart failure (New York Heart Stage 3-4),
morbid obesity (BMI 35)