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Longitudinal Innate Immunity and Aging Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03944603
Acronym
LIIA
Enrollment
300
Registered
2019-05-09
Start date
2019-04-30
Completion date
2025-03-31
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Older Adults Ages 60-89

Keywords

Alzheimer's Disease, Dementia, Older Adult, COVID-19, SARS-CoV-2

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.

Interventions

None listed

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 89 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Levels of Immune Protein Markers in Blood and CSF2-Year ChangesOutcome measures will include longitudinal changes in protein levels of blood inflammation and CSF inflammation
Performance on Neuropsychological Measures2-Year ChangesOutcome measures will include longitudinal changes in cognitive measures (e.g., memory and executive functions) over time
Levels of Exosomal Innate Immune Markers in Blood and CSF2-Year ChangesOutcome measures will include longitudinal changes in innate immune markers in exosomes (i.e., extracellular vesicles)

Secondary

MeasureTime frameDescription
Brain StructureBaselineOutcome measures will include baseline structural brain imaging
CSF Levels of Alzheimer's Disease Related Markers2-year changeOutcome measures will include CSF levels of proteins associated with Alzheimer's disease pathology

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026