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

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ClinicalTrials.gov Identifier: NCT03256539
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Sleep Alzheimer Disease Cognitive Impairment Aging CBT Behavioral: Sleep intervention Behavioral: Placebo intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
Actual Study Start Date : August 12, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Number of participants enrolled to the study [ Time Frame: Up to 24 weeks following study initiation ]
  2. Number of participants that complete the study [ Time Frame: Through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Sleep as assessed by actigraphy [ Time Frame: Through study completion, an average of 1 year ]
    Week-long measurement using wrist actigraphy

  2. Cognitive function assessed by standard neurocognitive battery [ Time Frame: Through study completion, an average of 1 year ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256539


Contacts
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Contact: Yue Leng, PhD 4152214810 ext 6565 yue.leng@ucsf.edu

Locations
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United States, California
UCSF Recruiting
San Francisco, California, United States, 94121
Contact: Bernard Landavazo, MA    415-340-2708    bernard.landavazo@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Yue Leng, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03256539    
Other Study ID Numbers: 1K99AG056598-01 ( U.S. NIH Grant/Contract )
1K99AG056598-01 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders