NCT03944603 · ACTIVE NOT RECRUITING
Longitudinal Innate Immunity and Aging Study
This observational study tracks healthy adults ages 60 to 89 over two years to understand how immune system markers in blood and spinal fluid relate to cognitive aging. No drug or intervention is involved — researchers are collecting data to identify what biological signals might predict cognitive decline or Alzheimer's risk. Because there is no treatment being tested, this is a research observation study, not a clinical trial in the traditional sense.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-04-02