Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorMassachusetts General Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

1. Subjective Cognitive Concerns (SCC), 2. Mild Cognitive Impairment, 3. Mild Behavioral Impairment, 4. Healthy Age-matched Controls.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • AROMHA Brain Health Test

    Device

    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.

Treatment groups

250 Participants
are divided into 4 treatment groups
Group A: Subjective Cognitive Concerns (SCC)1 intervention
Group B: Mild Cognitive Impairment (MCI)1 intervention
Group C: Mild Behavioral Impairment [prominent apathy] (MBI)1 intervention
Group D: Age-matched Controls1 intervention

Trial outcomes

Primary outcomes

1

AROMHA Brain Health Test

The AROMHA Brain Health Test is a battery of 18 odors across 5 smell cards. The subject smells each odor label and is tested on odor intensity, identification, memory, and discrimination. An increased number of correct responses indicates a better sense of smell. We will evaluate MCI patients' performance against age-matched controls.

Time frame
1 hour

Secondary outcomes

1

AROMHA Brain Health Test

The AROMHA Brain Health Test is a battery of 18 odors across 5 smell cards. The subject smells each odor label and is tested on odor intensity, identification, memory, and discrimination. An increased number of correct responses indicates a better sense of smell. We will evaluate MBI patients' performance against age-matched controls.

Time frame
1 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.