Longitudinal Innate Immunity and Aging Study

Active, not recruiting

• Conditions: Healthy Older Adults Ages 60-89

• Registration Number: NCT03944603
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-04
• Study Start: 2019-04-30
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Performance on Neuropsychological Measures	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	2-Year Changes	Outcome measures will include longitudinal changes in innate immune markers in exosomes (i.e., extracellular vesicles)

Secondary Outcome Measures

Name	Time	Method
Brain Structure	Baseline	Outcome measures will include baseline structural brain imaging
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

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States