NCT05881239

Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Subjective Cognitive Concerns
• Mild Cognitive Impairment
• Mild Behavioral Impairment
• Healthy Aging

Interventions

Type	Name	Description
DEVICE	AROMHA 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.

Timeline

• Start date: 2023-05-09
• Primary completion: 2026-12-30
• Completion: 2027-12-31
• First posted: 2023-05-31
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States