Crownlands Observing Progression With Neurons I (CROWN-I)
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.
• 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.
• Not pregnant or lactating.
• Medications stable ≥ 4 weeks before screening.
• GDS-15 \< 6 (i.e., 0-5 inclusive; no current significant depression).
• Available study partner who has known the participant for ≥ 12 months, maintains \
⁃ 10+ hours per week of in-person or telephone contact, and is willing to attend study visits and complete informant-rated assessments.
• Willing to complete olfactory brushing, smell testing, and venous blood draw.
• Willing to commit to baseline and follow-up visits across study duration.
• In the opinion of the Investigator, able to comply with the protocol-specified visit schedule and procedures for the full study duration.