Alzheimer s DiseaseCROWN-INCT07611396
Crownlands Observing Progression With Neurons Study
An observational study of Alzheimer s Disease and Mild Cognitive Impairment (MCI), run by Crownlands at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer s Disease, Mild Cognitive Impairment (MCI)
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2026to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: United States
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
- Cognitively Normal (CN) Additional Inclusion Criteria (CN)
- 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.
- Additional Exclusion Criteria (CN)
- 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).
- Mild Cognitive Impairment (MCI) Additional Inclusion Criteria (MCI)
- 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).
- Alzheimer's Disease (AD) Additional Inclusion Criteria (AD)
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Capital Neurology
Germantown, Maryland, 20876
About this study
Official title: 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.
Read the detailed description
Neurological diseases are difficult to characterize at the molecular level because disease-relevant tissue is rarely available in clinical practice. As a result, precision approaches in neurology have historically relied on indirect measures, including clinical assessments, neuroimaging, and biomarkers measured in blood, cerebrospinal fluid (CSF), and other biofluids. Although these tools have advanced diagnosis and monitoring, they provide limited access to neuron-specific and high-dimensional molecular information.
CROWN-I is a data-intensive longitudinal observational study designed to expand molecular and clinical characterization of Alzheimer's disease (AD) and mild cognitive impairment (MCI). The CROWN-I Study aims to track multiple high-dimensional molecular readouts in participants with AD and MCI as well as cognitively normal controls (CN). Participants will provide biospecimens at multiple time points and complete medical histories and clinical and cognitive assessments.
The study will analyze molecular signatures from olfactory neuron samples and blood. These data will be used to differentiate participant subgroups and may inform new therapeutic and clinical strategies for disease-modifying medicines.
- Keywords
- alzheimer's, longitudinal, genetics, olfactory neurons, biomarkers
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease (AD) | Participants with diagnosed Alzheimer's disease | |
| Mild cognitive impairment (MCI) | Participants with diagnosed or apparent MCI | |
| Cognitively normal | Participants who are cognitively normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the observational period at 18 months or final visit
Change in olfactory neuron transcriptomic profile
Change from baseline in olfactory neurons measured by Gateway in transcriptomic pathways associated with AD by human genetics.
Measured: From enrollment to the end of the observational period at 18 months or final visit
Secondary outcomes (8)
Change in p-tau217 in blood plasma
Change in quantitative levels of p-tau217 in blood plasma over the study observational period.
Measured: From enrollment to the end of the observational period at 18 months or final visit
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.
Measured: From enrollment to the end of the observational period at 18 months or final visit
Change in whole blood transcriptomic profile
Change from baseline in transcriptomic pathways associated with AD by human genetics in whole blood.
Measured: From enrollment to the end of the observational period at 18 months or other endpoint
Change in plasma proteomic profile
Change from baseline in proteomic pathways associated with AD in plasma.
Measured: From enrollment to the end of the observational period at 18 months or other endpoint
Cross-sectional differences in olfactory neuron transcriptomics
Difference between participants in different cohorts in olfactory neurons measured by Gateway in transcriptomic pathways associated with AD by human genetics.
Measured: Baseline
Change in clinical diagnosis
Measuring new clinical diagnoses of MCI and/or AD in participants without the diagnosis at the first visit
Measured: From enrollment to the end of the observational period at 18 months or final visit
Rate of change in MMSE
A secondary outcome is longitudinal changes from baseline in Mini-Mental State Examination, a 30-point evaluation where lower scores indicate cognitive worsening.
Measured: From enrollment to the end of the observational period at 18 months or final visit
Rate of change on RAVLT
A secondary outcome is longitudinal changes from baseline in Rey Auditory Verbal Learning Test, an assessment where lower scores indicate worsening episodic memory.
Measured: From enrollment to the end of the observational period at 18 months or final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start19 May 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crownlands
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611396
- Sponsor's protocol ID
- CLNDS-16530
- Acronym
- CROWN-I
- Status last verified
- Jun 2026
- First submitted
- 14 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crownlands Observing Progression With Neurons I (CROWN-I)
- ClinicalTrials.gov ID
- NCT07611396
- Acronym / sponsor ID
- CROWN-I / CLNDS-16530
- Keywords
- alzheimer's, longitudinal, genetics, olfactory neurons, biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- CrownlandsIndustry (pharma, biotech, devices)
- Study start
- 19 May 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neurological diseases are difficult to characterize at the molecular level because disease-relevant tissue is rarely available in clinical practice. As a result, precision approaches in neurology have historically relied on indirect measures, including clinical assessments, neuroimaging, and biomarkers measured in blood, cerebrospinal fluid (CSF), and other biofluids. Although these tools have advanced diagnosis and monitoring, they provide limited access to neuron-specific and high-dimensional molecular information.
CROWN-I is a data-intensive longitudinal observational study designed to expand molecular and clinical characterization of Alzheimer's disease (AD) and mild cognitive impairment (MCI). The CROWN-I Study aims to track multiple high-dimensional molecular readouts in participants with AD and MCI as well as cognitively normal controls (CN). Participants will provide biospecimens at multiple time points and complete medical histories and clinical and cognitive assessments.
The study will analyze molecular signatures from olfactory neuron samples and blood. These data will be used to differentiate participant subgroups and may inform new therapeutic and clinical strategies for disease-modifying medicines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease (AD) | – | –Participants with diagnosed Alzheimer's disease |
| Mild cognitive impairment (MCI) | – | –Participants with diagnosed or apparent MCI |
| Cognitively normal | – | –Participants who are cognitively normal |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- United States
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (36 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of change in CDR-SB
Time frame: From 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 profile
Time frame: From 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.
8 secondary outcomes
Change in p-tau217 in blood plasma
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Change in Aβ42/Aβ40 in blood plasma
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Change in whole blood transcriptomic profile
Time frame: From enrollment to the end of the observational period at 18 months or other endpoint
Change in plasma proteomic profile
Time frame: From enrollment to the end of the observational period at 18 months or other endpoint
Cross-sectional differences in olfactory neuron transcriptomics
Time frame: Baseline
Change in clinical diagnosis
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Rate of change in MMSE
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Rate of change on RAVLT
Time frame: From enrollment to the end of the observational period at 18 months or final visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer s Disease and Mild Cognitive Impairment (MCI), run by Crownlands at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mason Sanfilippo, MS ((415) 623-8635, m.sanfilippo@crownlands.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in CDR-SB (time frame: From enrollment to the end of the observational period at 18 months or final visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.