CROWN-I Study for Alzheimer's Disease and Mild Cognitive Impairment
The CROWN-I Study is an observational study looking at Alzheimer's disease (AD) and mild cognitive impairment (MCI). This study aims to understand the molecular and genetic differences that exist among patients and how these differences might predict how AD progresses. Researchers will collect samples and conduct assessments to identify molecular signatures from olfactory neuron samples (nerve cells involved in smell) and blood. The study is open to people aged 55 and older who have AD or MCI. Success will be measured by how much a person's cognitive decline changes over time (CDR-SB score) and changes in the genetic profile of their olfactory neurons over 18 months. The current recruitment status is unclear.
- Study design
- This is an observational study with a planned enrollment of 160 participants. It is designed to track multiple molecular and clinical changes over time.
- What's involved
- You will visit clinical sites multiple times to donate samples and complete virtual and in-person clinical assessments over an 18-month period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be observed for 18 months or until their final visit.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07611396
Crownlands Observing Progression With Neurons Study
Recruiting
Not specifiedAges 55+ObservationalCrownlands
~160 participants
Updated 2026-06-04 on ClinicalTrials.gov
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of change in CDR-SB
Measured over From enrollment to the end of the observational period at 18 months or final visit
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
No subjective cognitive complaint reported by participant AND no cognitive -complaint reported by study partner.
No current or prior clinical diagnosis of MCI, Alzheimer's disease, or any other dementia, and no current clinical diagnosis of a neurological or neuropsychiatric disease.
MMSE score ≥ 27 / 30 at Screening.
Global Clinical Dementia Rating (CDR) = 0 at Screening.
CDR Sum of Boxes (CDR-SB) = 0 at Screening.
Performance within 1.0 standard deviation of demographically adjusted norms on the Rey Auditory Verbal Learning Test (RAVLT) Delayed Recall.
Subjective cognitive complaint reported by participant OR partner-verified memory complaint reported by study partner.
MMSE score ≥ 24 and ≤ 30 at Screening.
Global CDR = 0.5 at Screening.
CDR-SB ≥ 0.5 and \< 3 at Screening; CDR Memory Box ≥ 0.5.
Performance ≥ 1.5 standard deviations below demographically adjusted norms on the RAVLT Delayed Recall (or equivalent episodic memory criterion per the Petersen / NIA-AA MCI framework).
Preserved general functional ability such that the participant does not meet criteria for dementia (i.e., does not meet AD criteria in Section 7.3).
Confirmed clinical diagnosis of probable Alzheimer's disease by a qualified specialist (cognitive neurologist, geriatric psychiatrist, or equivalent), consistent with NIA-AA 2011 (McKhann et al.) or NIA-AA 2018 Research Framework biological criteria.
MMSE score ≥ 16 and ≤ 26 at Screening.
Global CDR ≥ 1 at Screening.
CDR-SB ≥ 3 at Screening.
CDR Memory Box score ≥ 0.5 at Screening.
Partner-verified history of progressive cognitive decline of ≥ 6 months duration.
Functional impairment consistent with dementia, as documented on the CDR Functional Domains (Community Affairs, Home \& Hobbies, Personal Care); participant able to complete protocol.
Exclusion
Current or active clinically significant neurological disorder (in the opinion of the Investigator) other than the disorders in the study arms, including but not limited to:
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.
Active malignancy under treatment, or malignancy with expected survival \< 30 months (excluding non-melanoma skin cancer and localized prostate cancer on active surveillance).
Participation in studies collecting neuropsychological measures more than once per year.
Presence of previous nasal surgery or other anatomical abnormalities that could interfere with the procedure on both sides of the nose, at the discretion of the clinician administering the Olfactory Brushing.
Active respiratory infection or recent history of respiratory infection within the past two weeks.
Known allergy or adverse reaction to topical anesthetics or decongestants used in the study (e.g., lidocaine, tetracaine, oxymetazoline).
Any other medical or psychiatric condition or lab abnormality that, in the opinion of the Investigator, might preclude participation or render the participant unsuitable for study enrollment.
Current or prior use of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for any indication.
Current or prior use of anti-amyloid monoclonal antibody disease-modifying therapy (aducanumab, lecanemab, donanemab, or any investigational anti-amyloid mAb).
What this trial measures
- Rate of change in CDR-SBFrom enrollment to the end of the observational period at 18 months or final visit
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.
- Change in olfactory neuron transcriptomic profileFrom enrollment to the end of the observational period at 18 months or final visit
Change from baseline in olfactory neurons measured by Gateway in transcriptomic pathways associated with AD by human genetics.