Start: May 1, 2016
End: May 2021
What Is This Study About?
Circadian rhythm disorders occur in most people with dementia. Symptoms include late afternoon/evening agitation (e.g., sundowning) and irregular sleep-wake rhythms such as daytime excessive sleepiness, frequent night waking, and poor sleep efficiency. This Phase 3 clinical trial will evaluate a one-month, eight-session program that provides training for caregivers on home-based activities to improve the sleep-wake patterns of dementia care recipients who live at home. The study involves in-home visits and telephone-based sessions from a trainer, and practice of each activity under the supervision of the trainer and then on their own. Some participants will be randomized to a control group and receive general education about circadian rhythm disorders. In both groups, the person with dementia will wear a bracelet that measures waking and sleeping time and will be evaluated for neuropsychiatric behaviors.
Do I Qualify To Participate in This Study?
- Over age 60
- English speaking
- Able to tolerate a wristwatch for a month
- Diagnosis of dementia
- Symptoms of circadian rhythm disorders, as reported by caregiver
- If taking any psychotropic medications (antidepressant, benzodiazepine, antipsychotic, or anticonvulsant) or an anti-dementia medication (memantine or cholinesterase inhibitor), on a stable dose for 90 days prior to enrollment
- At least 18 years old
- Living close to the care recipient and planning to stay in the area for at least six months
- If taking a psychotropic medication, on a stable dose for at least 60 days
Must NOT have:
- In a crisis/unsafe situation
- Planning to move to another residential or care setting within six months
- At end-stage disease (e.g., bed-bound, noncommunicative, on hospice)
- Currently enrolled in a clinical trial for dementia or associated symptoms
- Prohibited medications when used regularly: medications with substantial known effects on the measurement of hypothalamic pituitary adrenal axis activity (e.g., corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy)
- Major surgery in the past three months
- History of major psychiatric and/or personality disorder
- History of heavy cigarette smoking
- Loss of a loved one in the past three months
- 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, or morbid obesity
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: University of Pennsylvania
Source: ClinicalTrials.gov ID: NCT03682185