Longitudinal Innate Immunity and Aging Study

NCT ID: NCT03944603

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2025-03-31

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.

Conditions

Healthy Older Adults Ages 60-89

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

R01AG058772

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-2607

Identifier Type: -

Identifier Source: org_study_id