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RecruitingAlzheimer s DiseaseMild Cognitive Impairment (MCI)

Crownlands Observing Progression With Neurons Study

Eligible age

55+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

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.

Sponsor: Crownlands

You may qualify if…

  • 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.

You may not qualify if…

  • 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.

Where it's recruiting

Maryland

Germantown

Source: ClinicalTrials.gov · NCT07611396 · last updated 2026-06-04

Crownlands Observing Progression With Neurons Study · TrialPath