Clinical trial NCT03256539: Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
Official title: Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Alzheimer Disease
Cognitive Impairment
Aging
CBT
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-08-22
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light therapy and a modified cognitive behavioral therapy for insomnia will be developed to address 24-hour patterns of sleep. We will then pilot test its feasibility and explore its preliminary effects on improving sleep/napping and cognition in patients with MCI or mild Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* ≥65 years old
* Memory complaints verified by an informant
* Clinical diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease
* General cognitive performance sufficiently persevered such that a diagnosis of Alzheimer's disease cannot be made by the site physician
* No evidence (CT or MRI scans within 12 months prior to screening) of infection, infarction, or other focal lesions and no clinical symptoms suggestive of intervening neurological disease
* Adequate visual and auditory acuity to allow neuropsychological testing
* Meets ICSD-2 criteria for insomnia or circadian rhythm disorders, or shows actigraphy evidence of sleep disturbances and excessive napping

Exclusion Criteria:

* Any major neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, multiple sclerosis, seizure disorder, Huntington's disease, brain tumor or history of significant head trauma
* Any comorbid psychiatric conditions or severe personality disorder within the past 2 years (by DSM-IV), such as major depression, bipolar disorder, schizophrenia and other psychotic features
* Any uncontrolled medical conditions or systemic illness that might lead to difficulty complying with the study protocol
* History of alcohol or substance abuse within the past 2 years
* Any inadequately treated primary or secondary sleep disorder (due to medical conditions) that might confound the association

Primary outcomes:
measure: Number of participants enrolled to the study
timeFrame: Up to 24 weeks following study initiation
measure: Number of participants that complete the study
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Sleep as assessed by actigraphy
timeFrame: Through study completion, an average of 1 year
measure: Cognitive function assessed by standard neurocognitive battery
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Yue Leng, PhD
role: PRINCIPAL_INVESTIGATOR
References: