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出境医 / 临床实验 / Longitudinal Innate Immunity and Aging Study (LIIA)
Longitudinal Innate Immunity and Aging Study (LIIA)
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 |
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 30, 2019 |
| Estimated Primary Completion Date : | March 31, 2024 |
| Estimated Study Completion Date : | March 31, 2024 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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 Outcome Measures :
- Brain Structure [ Time Frame: Baseline ]Outcome measures will include baseline structural brain imaging
- 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 Years 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
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
Contacts and Locations
Contacts
| Contact: Neurology Reserach Partners | 303-724-4644 | neurologyresearchpartners@ucdenver.edu | |
| Contact: Michelle Stocker | 303-724-2048 | michelle.stocker@cuanschutz.edu |
Locations
| United States, Colorado | |
| University of Colorado Anschutz Medical Campus | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Michelle Stocker 303-724-2048 michelle.stocker@cuanschutz.edu | |
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Aging (NIA)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 4, 2019 | ||||||||
| First Posted Date | May 9, 2019 | ||||||||
| Last Update Posted Date | May 21, 2021 | ||||||||
| Actual Study Start Date | April 30, 2019 | ||||||||
| Estimated Primary Completion Date | March 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Longitudinal Innate Immunity and Aging Study | ||||||||
| Official Title | Investigating the Contribution of Peripheral Versus Central Nervous System Dysfunction to Cognitive Aging | ||||||||
| 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 Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Healthy older adults | ||||||||
| Condition | Healthy Older Adults Ages 60-89 | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
300 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | March 31, 2024 | ||||||||
| Estimated Primary Completion Date | March 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 60 Years to 89 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03944603 | ||||||||
| Other Study ID Numbers | 18-2607 R01AG058772 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University of Colorado, Denver | ||||||||
| Study Sponsor | University of Colorado, Denver | ||||||||
| Collaborators | National Institute on Aging (NIA) | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | University of Colorado, Denver | ||||||||
| Verification Date | May 2021 | ||||||||
