Longitudinal Innate Immunity and Aging Study

Study Overview
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Brief Summary
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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.

Official Title
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Investigating the Contribution of Peripheral Versus Central Nervous System Dysfunction to Cognitive Aging

Conditions
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Healthy Older Adults Ages 60-89

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between ages of 60-89 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 Mini Mental State Examination (MMSE) >23 Clinical Dementia Rating (CDR) global score of 0 No informant report of significant cognitive decline in prior year No evidence from the screening visit suggesting a neurodegenerative disorder (per team neurologist) Willingness to complete both baseline and 2-year follow-up procedures Exclusion Criteria: Major psychiatric disorder (e.g. schizophrenia, bipolar disorder, untreated major depression within past year) 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) CNS immune conditions and other conditions affecting cognition (e.g., multiple sclerosis, paraneoplastic encephalitides; Hashimoto's encephalopathy; systematic lupus erythematosus) Systematic illness (e.g.,current cancer, renal failure, respiratory failure) Substance abuse/dependence (DSM-V criteria) Current medication use likely to affect CNS (e.g., long-acting benzodiazepines, neuroleptics in the phenothiazine and haloperidol families) 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]. Significant sensory or motor deficits that would interfere with cognitive testing Factors that preclude MR imaging (e.g., pacemaker) Factors that preclude lumbar puncture

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Immune Protein Markers in Blood and CSF | Outcome measures will include longitudinal changes in protein levels of blood inflammation and CSF inflammation | 2-Year Changes | 
| Performance on Neuropsychological Measures | Outcome measures will include longitudinal changes in cognitive measures (e.g., memory and executive functions) over time | 2-Year Changes | 
| Levels of Exosomal Innate Immune Markers in Blood and CSF | Outcome measures will include longitudinal changes in innate immune markers in exosomes (i.e., extracellular vesicles) | 2-Year Changes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Structure | Outcome measures will include baseline structural brain imaging | Baseline | 
| CSF Levels of Alzheimer's Disease Related Markers | Outcome measures will include CSF levels of proteins associated with Alzheimer's disease pathology | 2-year change | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, Dementia, Older Adult, COVID-19, SARS-CoV-2