<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03256539</url>
  </required_header>
  <id_info>
    <org_study_id>1K99AG056598-01</org_study_id>
    <secondary_id>1K99AG056598-01</secondary_id>
    <nct_id>NCT03256539</nct_id>
  </id_info>
  <brief_title>Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease</brief_title>
  <official_title>Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting&#xD;
      improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive&#xD;
      impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light&#xD;
      therapy and a modified cognitive behavioral therapy for insomnia will be developed to address&#xD;
      24-hour patterns of sleep. We will then pilot test its feasibility and explore its&#xD;
      preliminary effects on improving sleep/napping and cognition in patients with MCI or mild&#xD;
      Alzheimer's disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 12, 2021</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants enrolled to the study</measure>
    <time_frame>Up to 24 weeks following study initiation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants that complete the study</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep as assessed by actigraphy</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Week-long measurement using wrist actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function assessed by standard neurocognitive battery</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Sleep</condition>
  <condition>Alzheimer Disease</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Aging</condition>
  <condition>CBT</condition>
  <arm_group>
    <arm_group_label>Sleep Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep intervention</intervention_name>
    <description>Behavioral sleep intervention program</description>
    <arm_group_label>Sleep Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo intervention</intervention_name>
    <description>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)</description>
    <arm_group_label>Placebo intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥65 years old&#xD;
&#xD;
          -  Memory complaints verified by an informant&#xD;
&#xD;
          -  Clinical diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease&#xD;
&#xD;
          -  General cognitive performance sufficiently persevered such that a diagnosis of&#xD;
             Alzheimer's disease cannot be made by the site physician&#xD;
&#xD;
          -  No evidence (CT or MRI scans within 12 months prior to screening) of infection,&#xD;
             infarction, or other focal lesions and no clinical symptoms suggestive of intervening&#xD;
             neurological disease&#xD;
&#xD;
          -  Adequate visual and auditory acuity to allow neuropsychological testing&#xD;
&#xD;
          -  Meets ICSD-2 criteria for insomnia or circadian rhythm disorders, or shows actigraphy&#xD;
             evidence of sleep disturbances and excessive napping&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any major neurologic disease other than suspected incipient Alzheimer's disease, such&#xD;
             as Parkinson's disease, multi-infarct dementia, multiple sclerosis, seizure disorder,&#xD;
             Huntington's disease, brain tumor or history of significant head trauma&#xD;
&#xD;
          -  Any comorbid psychiatric conditions or severe personality disorder within the past 2&#xD;
             years (by DSM-IV), such as major depression, bipolar disorder, schizophrenia and other&#xD;
             psychotic features&#xD;
&#xD;
          -  Any uncontrolled medical conditions or systemic illness that might lead to difficulty&#xD;
             complying with the study protocol&#xD;
&#xD;
          -  History of alcohol or substance abuse within the past 2 years&#xD;
&#xD;
          -  Any inadequately treated primary or secondary sleep disorder (due to medical&#xD;
             conditions) that might confound the association&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yue Leng, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yue Leng, PhD</last_name>
    <phone>4152214810</phone>
    <phone_ext>6565</phone_ext>
    <email>yue.leng@ucsf.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>UCSF</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bernard Landavazo, MA</last_name>
      <phone>415-340-2708</phone>
      <email>bernard.landavazo@ucsf.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03256539
org study id: 1K99AG056598-01
secondary id: 1K99AG056598-01
nct id: NCT03256539
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Number of participants enrolled to the study
time frame: Up to 24 weeks following study initiation
measure: Number of participants that complete the study
time frame: Through study completion, an average of 1 year
measure: Sleep as assessed by actigraphy
time frame: Through study completion, an average of 1 year
description: Week-long measurement using wrist actigraphy
measure: Cognitive function assessed by standard neurocognitive battery
time frame: Through study completion, an average of 1 year
arm group label: Sleep Intervention
arm group type: Experimental
description: Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT)
arm group label: Placebo intervention
arm group type: Placebo Comparator
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).
intervention type: Behavioral
intervention name: Sleep intervention
description: Behavioral sleep intervention program
arm group label: Sleep Intervention
intervention type: Behavioral
intervention name: Placebo intervention
description: 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)
arm group label: Placebo intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Yue Leng, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Yue Leng, PhD
phone: 4152214810
phone ext: 6565
email: yue.leng@ucsf.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction
sharing ipd: No