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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
160 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov