Longitudinal Innate Immunity and Aging Study
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03944603 Recruiting May 9, 2019 May 21, 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
Phase: N/A
Detailed Description


study design
Study Type: Observational
Estimated Enrollment : 300 participants
Intervention Model : N/A
Masking: N/A
Primary Purpose: N/A
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: March 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

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

Contacts and Locations

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

Contact: Michelle Stocker 303-724-2048 michelle.stocker@cuanschutz.edu

United States, Colorado University of Colorado Anschutz Medical Campus Aurora
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Aging (NIA)
More Information
Responsible Party : University of Colorado, Denver
ClinicalTrials.gov Identifier : NCT03944603     
Other Study ID Numbers : 18-2607, R01AG058772
First Posted : May 9, 2019
Last Update Posted : May 21, 2021
Last Verified : May 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: Alzheimer's Disease
Older Adult