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Trial record 1 of 1 for:    NCT03944603
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Longitudinal Innate Immunity and Aging Study (LIIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03944603
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : May 21, 2021
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Colorado, Denver

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
Healthy Older Adults Ages 60-89

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Study Type : Observational
Estimated 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 : April 30, 2019
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Levels of Immune Protein Markers in Blood and CSF [ Time Frame: 2-Year Changes ]
    Outcome measures will include longitudinal changes in protein levels of blood inflammation and CSF inflammation

  2. Performance on Neuropsychological Measures [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline ]
    Outcome measures will include baseline structural brain imaging

  2. CSF Levels of Alzheimer's Disease Related Markers [ Time Frame: 2-year change ]
    Outcome measures will include CSF levels of proteins associated with Alzheimer's disease pathology

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy older adults

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

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 identifier (NCT number): NCT03944603

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Contact: Neurology Reserach Partners 303-724-4644
Contact: Michelle Stocker 303-724-2048

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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Michelle Stocker    303-724-2048   
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Aging (NIA)
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Responsible Party: University of Colorado, Denver Identifier: NCT03944603    
Other Study ID Numbers: 18-2607
R01AG058772 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 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
Keywords provided by University of Colorado, Denver:
Alzheimer's Disease
Older Adult