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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03256539
• Other study ID #: 1K99AG056598-01
• Secondary ID: 1K99AG056598-01R
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: Yue Leng, PhD
• Phone: 4152214810
• Email: yue.leng[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Alzheimer Disease
• CBT
• Cognitive Dysfunction
• Cognitive Impairment
• Sleep

Intervention

Behavioral:
• Sleep intervention
Behavioral sleep intervention program
• Placebo intervention
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)

Locations

Country	Name	City	State
United States	UCSF	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants enrolled to the study		Up to 24 weeks following study initiation
Primary	Number of participants that complete the study		Through study completion, an average of 1 year
Secondary	Sleep as assessed by actigraphy	Week-long measurement using wrist actigraphy	Through study completion, an average of 1 year
Secondary	Cognitive function assessed by standard neurocognitive battery		Through study completion, an average of 1 year