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

NCT03256539 | Terminated Results

• 2 other identifiers: 1K99AG056598-01R00AG056598
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Alzheimer Disease; Cognitive Impairment; Aging; CBT

Outcome Measures

Primary Outcomes (2)

• Number of Participants Enrolled to the Study

  Up to 24 weeks following study initiation

• Number of Participants That Complete the Study

  Through study completion, up to 34 weeks

Secondary Outcomes (2)

• Sleep as Assessed by Actigraphy

  Through study completion, up to 34 weeks

• Cognitive Function Assessed by Standard Neurocognitive Battery

  Through study completion, up to 34 weeks

Study Arms (2)

Sleep Intervention

EXPERIMENTAL

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

Behavioral: Sleep intervention

Placebo intervention

PLACEBO COMPARATOR

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).

Behavioral: Placebo intervention

Interventions

Sleep intervention BEHAVIORAL

Behavioral sleep intervention program

Sleep Intervention

Placebo intervention BEHAVIORAL

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)

Placebo intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UCSF

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Dr. Yue Leng
• Organization: University of California, San Francisco

yue.leng@ucsf.edu

415 502 2949

Study Officials

• Yue Leng, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 22, 2017
• Study Start: August 12, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)