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Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a smell test can help predict diseases that damage the brain. It is for people with memory or thinking concerns, mild thinking or behavior changes, and people of similar ages without these conditions. The test takes about 45 minutes and uses peel-and-sniff cards and an online app; participants will not get their test results.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 100 years old when joining.
  • Have a medical or research team confirm your condition or your status as someone without the conditions being studied.

Who can't join

  • Have a main lung disease, such as severe emphysema (lung damage) or asthma that is not well controlled.
  • Currently have a sinus infection, cold, other upper airway infection, or nasal polyps (growths inside the nose).
  • Have alcohol or drug dependence now or within the past 6 months. Earlier alcohol or drug abuse alone does not rule you out.
  • Be pregnant.
  • Have thinking problems severe enough to keep you from finishing the smell test.
  • Have a bad reaction to scents, such as a severe asthma attack or nausea.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

MA