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LIIA: Longitudinal Innate Immunity and Aging Study

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT03944603
Collaborator
National Institute on Aging (NIA) (NIH)
300
Enrollment
1
Location
59
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study plans to examine biological bases of cognitive aging. The goals of the study are to better understand how immune system markers, measured in the blood and in the spinal fluid, are related to clinical features of aging over time. The study also aims to better understand how different types of biomarkers may relate to immune health and the aging process. This research may ultimately help us better understand what puts individuals at risk for cognitive decline and for Alzheimer's disease.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Investigating the Contribution of Peripheral Versus Central Nervous System Dysfunction to Cognitive Aging
    Actual Study Start Date :
    Apr 30, 2019
    Anticipated Primary Completion Date :
    Mar 31, 2024
    Anticipated Study Completion Date :
    Mar 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Levels of Immune Protein Markers in Blood and CSF [2-Year Changes]

      Outcome measures will include longitudinal changes in protein levels of blood inflammation and CSF inflammation

    2. Performance on Neuropsychological Measures [2-Year Changes]

      Outcome measures will include longitudinal changes in cognitive measures (e.g., memory and executive functions) over time

    3. Levels of Exosomal Innate Immune Markers in Blood and CSF [2-Year Changes]

      Outcome measures will include longitudinal changes in innate immune markers in exosomes (i.e., extracellular vesicles)

    Secondary Outcome Measures

    1. Brain Structure [Baseline]

      Outcome measures will include baseline structural brain imaging

    2. CSF Levels of Alzheimer's Disease Related Markers [2-year change]

      Outcome measures will include CSF levels of proteins associated with Alzheimer's disease pathology

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Between ages of 60-89

    2. Have a reliable study partner who has frequent contact with the subject (i.e., at least twice per month) and is able to provide information about functional abilities

    3. Mini Mental State Examination (MMSE) >23

    4. Clinical Dementia Rating (CDR) global score of 0

    5. No informant report of significant cognitive decline in prior year

    6. No evidence from the screening visit suggesting a neurodegenerative disorder (per team neurologist)

    7. Willingness to complete both baseline and 2-year follow-up procedures

    Exclusion Criteria:

    1. Major psychiatric disorder (e.g. schizophrenia, bipolar disorder, untreated major depression within past year)

    2. Neurological conditions affecting cognition (e.g. Parkinson's disease, epilepsy (onset prior than 2 years ago), head trauma with loss of consciousness >5 min within past two years, large vessel infarct, mild cognitive impairment, or dementia)

    3. CNS immune conditions and other conditions affecting cognition (e.g., multiple sclerosis, paraneoplastic encephalitides; Hashimoto's encephalopathy; systematic lupus erythematosus)

    4. Systematic illness (e.g.,current cancer, renal failure, respiratory failure)

    5. Substance abuse/dependence (DSM-V criteria)

    6. Current medication use likely to affect CNS (e.g., long-acting benzodiazepines, neuroleptics in the phenothiazine and haloperidol families)

    7. Current medication use that precludes lumbar punctures (e.g. anticoagulants, antiplatelets, heparin shots, or some other blood thinner medications: Warfarin [coumadin], Pradaxa [dabigatran], Xarelto [rivaroxaban]. Eliquis [apixaban], or Plavix [clopidogrel].

    8. Significant sensory or motor deficits that would interfere with cognitive testing

    9. Factors that preclude MR imaging (e.g., pacemaker)

    10. Factors that preclude lumbar puncture

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver
    • National Institute on Aging (NIA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT03944603
    Other Study ID Numbers:
    • 18-2607
    • R01AG058772
    First Posted:
    May 9, 2019
    Last Update Posted:
    May 21, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Colorado, Denver
    Alzheimer's Disease
    Dementia
    Older Adult
    COVID-19
    SARS-CoV-2

    Study Results

    No Results Posted as of May 21, 2021