Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Aging; Alzheimer Disease; CBT; Cognitive Impairment; Sleep

Treatments: Behavioral: Sleep intervention; Behavioral: Placebo intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03256539

1K99AG056598-01 (U.S. NIH Grant/Contract)

R00AG056598 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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 International Classification of Sleep Disorders-2nd edition (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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

Sleep Intervention

Experimental group

Description:

Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT)

Treatment:

Behavioral: Sleep intervention

Placebo intervention

Placebo Comparator group

Description:

Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration).

Treatment:

Behavioral: Placebo intervention