RecruitingNCT05881239

Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

Sponsor

Massachusetts General Hospital

Enrollment

250 participants

Start Date

May 9, 2023

Study Type

OBSERVATIONAL

Conditions

Mild Cognitive Impairment Healthy Aging Subjective Cognitive Concerns Mild Behavioral Impairment

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study uses a remote, digital smell test to assess early changes in the sense of smell that may signal Alzheimer's disease or other brain conditions before symptoms appear. Smell loss is one of the earliest signs of Alzheimer's, and this study aims to develop a convenient, home-based test to detect it. **You may be eligible if...** - You are between 18 and 100 years old - You have been assessed by a clinician or research team and have a known diagnosis or control status **You may NOT be eligible if...** - You have severe lung disease such as emphysema or poorly controlled asthma - You currently have a sinus infection, cold, upper respiratory infection, or nasal polyps - You have had alcohol or substance dependence in the past 6 months - You are pregnant - You have severe cognitive impairment that prevents completing the smell test - You have severe reactions to fragrances (such as asthma attacks or nausea triggered by smells) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAROMHA Brain Health Test

The AROMHA Brain Health Test is a self-administered, at-home smell test developed as a potential primary screen for identifying individuals at risk for developing Alzheimer's and as a means to follow disease progression in individuals without overt cognitive symptoms. The smell test device consists of five physical smell cards and a paired web-based app that directs participants on how to sample odors and asks them questions regarding what they have smelled. The 45-minute smell test battery includes measures of odor intensity, identification, memory, and discrimination.