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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Sleep; Alzheimer Disease; Aging; CBT
• Intervention / Treatment: Behavioral: Sleep intervention; Behavioral: Placebo intervention

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yue Leng, PhD; Phone Number: 6565 4152214810; Email: yue.leng@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • Recruiting
      • UCSF
      • Contact: Bernard Landavazo, MA; Phone Number: 415-340-2708; Email: bernard.landavazo@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Intervention; Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT)	Behavioral: Sleep intervention; Behavioral sleep intervention program
Placebo Comparator: Placebo intervention; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants enrolled to the study	Up to 24 weeks following study initiation
Number of participants that complete the study	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep as assessed by actigraphy	Week-long measurement using wrist actigraphy	Through study completion, an average of 1 year
Cognitive function assessed by standard neurocognitive battery		Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Yue Leng, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 1K99AG056598-01 (U.S. NIH Grant/Contract); R00AG056598 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No