NCT07660887

Brief Summary

This prospective longitudinal cohort study will enroll adults aged 50 years and older to characterize olfactory dysfunction in aging. Participants will undergo comprehensive olfactory testing, cognitive assessment, biomarker collection, and imaging to identify clinically relevant phenotypes based on anatomic site of dysfunction. The study will also evaluate the impact of olfactory dysfunction on quality of life and identify baseline factors associated with changes in olfactory function over time.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
62mo left

Started Apr 2027

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2027

Expected
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2032

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2032

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

5.1 years

First QC Date

May 27, 2026

Last Update Submit

June 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Olfactory Function

    Olfactory Threshold, Discrimination, and Identification (TDI scores) using Sniffin' Sticks.

    Baseline

Secondary Outcomes (2)

  • Change in Olfactory Function Over Time

    Year 1 and year 2

  • Patient-Reported Outcomes

    Baseline, Year 1 and year 2

Study Arms (1)

Older Adults With and Without Olfactory Dysfunction

Adults aged 50 years and older enrolled in a prospective cohort study assessing olfactory function, cognition, biomarkers, and quality of life, with annual follow-up. Participants will be classified post hoc into olfactory phenotypes based on testing results.

Other: Clinical and Biomarker Assessments

Interventions

Participants undergo olfactory testing (Sniffin' Sticks), cognitive assessment, nasal endoscopy, olfactory mucus collection, MRI imaging (subset), and patient-reported outcome measures to evaluate olfactory function, biomarkers, and health outcomes over time.

Older Adults With and Without Olfactory Dysfunction

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community-dwelling adults aged 50 years and older recruited from the Medical University of South Carolina (MUSC) and surrounding community, including clinic patients and individuals responding to advertisements, who may have normal olfactory function or varying degrees of olfactory dysfunction.

You may qualify if:

  • Age: 50 years or older
  • Ability to follow instructions and understand consent process in English
  • Adequate visual, auditory, or motor functioning to complete items in the test battery or availability of assistance or assist devices to complete tasks

You may not qualify if:

  • \- Vulnerable populations including prisoners or institutionalized individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUSC

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Soler ZM, Gregoski MJ, Kohli P, LaPointe KA, Schlosser RJ. Development and validation of the four-item Concise Aging adults Smell Test to screen for olfactory dysfunction in older adults. Int Forum Allergy Rhinol. 2025 Mar;15(3):250-257. doi: 10.1002/alr.23476. Epub 2024 Oct 27.

    PMID: 39462307BACKGROUND

Central Study Contacts

Rodney Schlosser, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 22, 2026

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

April 30, 2032

Study Completion (Estimated)

April 30, 2032

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Protection of individual privacy

Locations