No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 and older
Sex
Any
Study type
Observational
Participants needed
160 (estimated)
Sponsor
Crownlands · Industry
Who this trial is looking for
This trial is looking for adults aged 55 and older with mild cognitive impairment or Alzheimer’s disease. Participants will undergo assessments and provide samples at clinical sites.
Are You a Good Fit for This Trial?
Rules you outParkinson's diseaseAlzheimer's diseaseMajor depression with active suicidalityActive malignancySeizure disorder
You may be able to join if
I am at least 55 years old.
I can read and speak English well enough to understand assessments.
I have a study partner who knows me well and can attend visits.
I have had stable medications for at least 4 weeks before screening.
I am not pregnant or breastfeeding.
I am willing to complete olfactory tests and blood draws.
I can attend all scheduled visits for the study duration.
I have no significant depression.
You may not be able to join if
I have a current significant neurological disorder.
I have had a major psychiatric illness in the past 6 months.
I have a current substance use disorder.
I have had a recent respiratory infection.
I have a known allergy to certain anesthetics or decongestants.
I had any nasal surgery that affects the procedure.
I have active cancer being treated.
I cannot comply with visit schedules.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 asse…
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.
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Status
Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
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.
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