The CROWN-I Study is an observational study to learn about molecular features of Alzheimer's disease (AD) and mild cognitive impairment (MCI). The primary objective is to identify the molecular and genetic modules that differentiate patient subtypes and predict progression of AD. Participants will visit clinical sites to donate samples multiple times and perform virtual and in-person clinical assessments.
Neurological diseases are difficult to characterize at the molecular level because disease-relevant tissue is rarely available in clinical practice. As a result, precision approaches in neurology have historically relied on indirect measures, including clinical assessments, neuroimaging, and biomarkers measured in blood, cerebrospinal fluid (CSF), and other biofluids. Although these tools have advanced diagnosis and monitoring, they provide limited access to neuron-specific and high-dimensional molecular information. CROWN-I is a data-intensive longitudinal observational study designed to expand molecular and clinical characterization of Alzheimer's disease (AD) and mild cognitive impairment (MCI). The CROWN-I Study aims to track multiple high-dimensional molecular readouts in participants with AD and MCI as well as cognitively normal controls (CN). Participants will provide biospecimens at multiple time points and complete medical histories and clinical and cognitive assessments. The study will analyze molecular signatures from olfactory neuron samples and blood. These data will be used to differentiate participant subgroups and may inform new therapeutic and clinical strategies for disease-modifying medicines.
Study Type
OBSERVATIONAL
Enrollment
160
Capital Neurology
Germantown, Maryland, United States
RECRUITINGRate of change in CDR-SB
The primary clinical outcomes are longitudinal changes from baseline in Clinical Dementia Rating - Sum of Boxes as administered by a qualified clinician. The CDR-SB evaluates six domains (memory, orientation, judgment, community affairs, home/hobbies, and personal care) for a total score ranging from 0 to 18, with increases indicating worsening impairment.
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Change in olfactory neuron transcriptomic profile
Change from baseline in olfactory neurons measured by Gateway in transcriptomic pathways associated with AD by human genetics.
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Change in p-tau217 in blood plasma
Change in quantitative levels of p-tau217 in blood plasma over the study observational period.
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Change in Aβ42/Aβ40 in blood plasma
Change in quantitative levels of amyloid β-peptide (Aβ) 42 : amyloid β-peptide (Aβ) 40 ratio in blood plasma over the study observational period.
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Change in whole blood transcriptomic profile
Change from baseline in transcriptomic pathways associated with AD by human genetics in whole blood.
Time frame: From enrollment to the end of the observational period at 18 months or other endpoint
Change in plasma proteomic profile
Change from baseline in proteomic pathways associated with AD in plasma.
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Time frame: From enrollment to the end of the observational period at 18 months or other endpoint
Cross-sectional differences in olfactory neuron transcriptomics
Difference between participants in different cohorts in olfactory neurons measured by Gateway in transcriptomic pathways associated with AD by human genetics.
Time frame: Baseline
Change in clinical diagnosis
Measuring new clinical diagnoses of MCI and/or AD in participants without the diagnosis at the first visit
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Rate of change in MMSE
A secondary outcome is longitudinal changes from baseline in Mini-Mental State Examination, a 30-point evaluation where lower scores indicate cognitive worsening.
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Rate of change on RAVLT
A secondary outcome is longitudinal changes from baseline in Rey Auditory Verbal Learning Test, an assessment where lower scores indicate worsening episodic memory.
Time frame: From enrollment to the end of the observational period at 18 months or final visit