Crownlands Observing Progression With Neurons Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorCrownlands
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Informed consent provided by the participant or, where applicable, Legally Authorized Representative (LAR) or other substitute decision-maker where permitted by applicable law, as described in Section 8.2.
Male or female, age ≥ 55 years at Screening.
Fluency of subject and study partner in English sufficient to complete all cognitive and self-report assessments without interpreter assistance.
Adequate visual and auditory acuity (with correction permitted) sufficient to complete neuropsychological testing.
Disqualifiers
Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, progressive supranuclear palsy, corticobasal degeneration, Huntington's disease, prion disease, multi-infarct dementia, normal pressure hydrocephalus, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, significant head trauma with persistent deficits, or known structural brain abnormalities.
Active or unstable major psychiatric illness (DSM-5 schizophrenia spectrum, bipolar I, or severe major depressive disorder with active suicidality) within 6 months prior to Screening; history of schizophrenia at any time.
Psychotic features, agitation, or behavioral problems within the last 3 months that could interfere with protocol compliance.
Current substance use disorder (DSM-5 moderate or severe), or alcohol use disorder within 24 months prior to Screening.
Trial population
United States
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 3 trial groupsGroup A: Alzheimer's disease (AD)
Group B: Mild cognitive impairment (MCI)
Group C: Cognitively normal
Trial outcomes
Primary outcomes
1
Rate 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 visit2
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 visitSecondary outcomes
1
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 visit2
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 visit3
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 endpoint4
Change in plasma proteomic profile
Change from baseline in proteomic pathways associated with AD in plasma.
Time frame
From enrollment to the end of the observational period at 18 months or other endpoint Source ClinicalTrials.gov