NCT05881239 Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD
| NCT ID | NCT05881239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Subjective Cognitive Concerns |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-05-09 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2023-05-09 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to objectively test one's sense of smell, called olfaction, in participants with Subjective Cognitive Concerns (SCC), Mild Cognitive Impairment, Mild Behavioral Impairment (MBI), and age-matched controls. The main question it aims to answer is whether the AROMHA Brain Health Test could serve as a predictive biomarker of neurodegenerative disorders. This understanding will aid in the development of a noninvasive, cost-effective diagnostic tool that reliably and specifically distinguishes disease and normal aging populations. Participants will take the approximately 45-minute AROMHA Brain Health Smell Test where they will peel and sniff labels on the physical smell cards and answer questions on the web-based app relating to what they smelled. Participants will undergo tests for odor intensity, odor identification, odor discrimination, and episodic olfactory memory, but will not be provided the results of these tests.
Eligibility Criteria
Inclusion Criteria: * A clinical or research consensus diagnosis of the patient's condition or control status. * Individuals that are at least 18 years of age at the time of enrollment. * Individuals that are no older than 100 years of age at the time of enrollment. Exclusion Criteria: * Primary pulmonary disease such as severe emphysema or asthma not under good medical control. * Current sinusitis, common cold, upper respiratory infection, or nasal polyps. * Current or recent (past 6 months) alcohol or substance dependence. A prior history of alcohol or substance abuse will not be grounds for exclusion. * Pregnancy. * Severe cognitive dysfunction that would preclude completion of the olfactory testing. * An adverse reaction to fragrances (ie. they trigger a severe asthmatic attack or nausea).
Contact & Investigator
Mark W Albers, MD PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05881239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Subjective Cognitive Concerns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05881239 currently recruiting?
Yes, NCT05881239 is actively recruiting participants. Contact the research team at albers.mark@mgh.harvard.edu for enrollment information.
Where is the NCT05881239 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05881239 clinical trial?
NCT05881239 is sponsored by Massachusetts General Hospital. The principal investigator is Mark W Albers, MD PhD at Massachusetts General Hospital. The trial plans to enroll 250 participants.