Healthy Older Adults Ages 60-89LIIANCT03944603
Longitudinal Innate Immunity and Aging Study
An observational study of Healthy Older Adults Ages 60-89, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Older Adults Ages 60-89
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy older adults
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Investigating the Contribution of Peripheral Versus Central Nervous System Dysfunction to Cognitive Aging
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.
- Conditions
- Healthy Older Adults Ages 60-89
- Keywords
- Alzheimer's Disease, Dementia, Older Adult, COVID-19, SARS-CoV-2
- Medical subject headings
- Alzheimer Disease, Dementia, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Immune Protein Markers in Blood and CSF
Outcome measures will include longitudinal changes in protein levels of blood inflammation and CSF inflammation
Measured: 2-Year Changes
Performance on Neuropsychological Measures
Outcome measures will include longitudinal changes in cognitive measures (e.g., memory and executive functions) over time
Measured: 2-Year Changes
Levels of Exosomal Innate Immune Markers in Blood and CSF
Outcome measures will include longitudinal changes in innate immune markers in exosomes (i.e., extracellular vesicles)
Measured: 2-Year Changes
Secondary outcomes (2)
Brain Structure
Outcome measures will include baseline structural brain imaging
Measured: Baseline
CSF Levels of Alzheimer's Disease Related Markers
Outcome measures will include CSF levels of proteins associated with Alzheimer's disease pathology
Measured: 2-year change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start30 Apr 2019
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Older Adults Ages 60-89Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944603
- Sponsor's protocol ID
- 18-2607
- Other IDs
- R01AG058772
- Acronym
- LIIA
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2019
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Contribution of Peripheral Versus Central Nervous System Dysfunction to Cognitive Aging
- ClinicalTrials.gov ID
- NCT03944603
- Acronym / sponsor ID
- LIIA / 18-2607
- Conditions
- Healthy Older Adults Ages 60-89
- Keywords
- Alzheimer's Disease, Dementia, Older Adult, COVID-19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy older adults
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
Brain Structure
Time frame: Baseline
CSF Levels of Alzheimer's Disease Related Markers
Time frame: 2-year change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Older Adults Ages 60-89, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Immune Protein Markers in Blood and CSF (time frame: 2-Year Changes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.