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Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Longitudinal Innate Immunity and Aging Study

Clinicaltrials.gov identifier NCT03944603

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted March 24, 2021

Study Description

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
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description


Study Design
  • 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 2019
  • Estimated Primary Completion Date: March 2024
  • Estimated Study Completion Date: May 2024
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 60 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

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

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

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

Contacts and Locations

Contact: Neurology Reserach Partners 303-724-4644 neurologyresearchpartners@ucdenver.edu

Contact: Katrina Bengtson 303-724-2048 katrina.bengtson@cuanschutz.edu


United States, Colorado
University of Colorado Anschutz Medical Campus

Sponsors and Collaborators

University of Colorado, Denver

National Institute on Aging (NIA)

More Information
  • Responsible Party: University of Colorado, Denver
  • ClinicalTrials.gov Identifier: NCT03944603 History of Changes
  • Other Study ID Numbers: 18-2607, R01AG058772
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: March 24, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing
  • Plan to Share IPD: No
  • 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: Dementia
    Older Adult
    Alzheimer's Disease