Actively Recruiting
Crownlands Observing Progression With Neurons I (CROWN-I) Study of Alzheimer's Disease and Mild Cognitive Impairment
Led by Crownlands · Updated on 2026-06-04
160
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Alzheimer's disease (AD) and mild cognitive impairment (MCI) to better understand molecular and genetic differences among patient subtypes and how these differences relate to disease progression. This observational study also includes cognitively normal participants as controls. The goal is to gather detailed molecular and clinical information that could inform future therapies and clinical strategies. Participants will provide samples such as olfactory neuron cells and blood at several visits over the study period. They will also complete cognitive and clinical assessments both in person and virtually. The study tracks changes over time, aiming to capture molecular signatures that distinguish different participant groups. During the study, participants will attend baseline and follow-up visits for up to 18 months. Assessments include cognitive tests like the Clinical Dementia Rating Sum of Boxes (CDR-SB), Mini-Mental State Examination (MMSE), and Rey Auditory Verbal Learning Test (RAVLT). Researchers will analyze changes in molecular profiles from olfactory neurons and blood, monitor progression of cognitive symptoms, and collect detailed medical histories. Participants will be observed for safety and adherence throughout the study.
CONDITIONS
Brief Title
Crownlands Observing Progression With Neurons Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent provided by participant or legally authorized representative
- Male or female aged 55 years or older at screening
- Fluent in English to complete all assessments without interpreter help
- Adequate vision and hearing to complete neuropsychological testing
- Not pregnant or lactating
- Stable medications for at least 4 weeks before screening
- GDS-15 score less than 6 indicating no significant depression
- Study partner known participant for at least 12 months and available for visits
- Willing to undergo olfactory brushing, smell testing, and blood draws
- Able and willing to complete baseline and follow-up visits throughout study
- Investigator opinion of ability to comply with study schedule and procedures
- Cognitively normal participants: no cognitive complaints, MMSE score 27 or higher, CDR global score 0, CDR-SB 0, and normal memory test performance
- MCI participants: memory complaint, MMSE 24 to 30, CDR 0.5, CDR-SB 0.5 to less than 3, impaired memory test performance, preserved general function without dementia
- Alzheimer's disease participants: diagnosed probable AD by specialist, MMSE 16 to 26, CDR 1 or higher, CDR-SB 3 or higher, history of progressive cognitive decline over 6 months, documented functional impairment but able to complete protocol
You will not qualify if you...
- Current or active significant neurological disorder besides study diagnoses (e.g., Parkinson's, Lewy body dementia, frontotemporal dementia)
- Active or unstable major psychiatric illness within 6 months before screening or history of schizophrenia
- Recent psychotic features, agitation, or behavioral problems interfering with study
- Current moderate or severe substance use disorder or recent alcohol use disorder
- Active cancer treatment or expected survival under 30 months (except some skin and prostate cancers)
- Participation in studies with neuropsychological measures more than once yearly
- Previous nasal surgery or nasal abnormalities affecting olfactory brushing
- Recent or active respiratory infection within 2 weeks
- Known allergy to topical anesthetics or decongestants used in study
- Any other medical or psychiatric condition deemed unsuitable by the investigator
- Cognitively normal participants: prior use of cholinesterase inhibitors or anti-amyloid antibody therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessments at enrollment
Participants complete medical histories and clinical and cognitive assessments to characterize Alzheimer's disease, mild cognitive impairment, or normal cognition.
1 baseline visit (in-person)
Duration - Up to 18 months
Participants provide biospecimens and undergo clinical and cognitive assessments over time to track molecular and clinical changes.
Multiple visits over 18 months for biospecimen collection and assessments
Trial Site Locations
Total: 1 location
1
Capital Neurology
Germantown, Maryland, United States, 20876
Actively Recruiting
Research Team
M
Mason Sanfilippo, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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