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Clinical Trials/NCT03944603
NCT03944603
Active, not recruiting
Not Applicable

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

University of Colorado, Denver1 site in 1 country300 target enrollmentApril 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Older Adults Ages 60-89
Sponsor
University of Colorado, Denver
Enrollment
300
Locations
1
Primary Endpoint
Levels of Immune Protein Markers in Blood and CSF
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 30, 2019
End Date
March 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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 Outcomes

  • Brain Structure(Baseline)
  • CSF Levels of Alzheimer's Disease Related Markers(2-year change)

Study Sites (1)

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