Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

Recruiting

• Conditions: Subjective Cognitive Concerns; Healthy Aging; Mild Behavioral Impairment; Mild Cognitive Impairment
• Interventions: Device: AROMHA Brain Health Test

• Registration Number: NCT05881239
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-09
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-12-30
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjective Cognitive Concerns (SCC)	AROMHA Brain Health Test	The composition of the proposed study population will reflect that of subjects recruited through the Longitudinal Cohort of the Massachusetts Alzheimer's Disease Research Center and that of patients treated by neurologists at the Memory and Movement Disorders Clinics at MGH as well as participants from the community.
Mild Cognitive Impairment (MCI)	AROMHA Brain Health Test	The composition of the proposed study population will reflect that of subjects recruited through the Longitudinal Cohort of the Massachusetts Alzheimer's Disease Research Center and that of patients treated by neurologists at the Memory and Movement Disorders Clinics at MGH as well as participants from the community.
Mild Behavioral Impairment [prominent apathy] (MBI)	AROMHA Brain Health Test	The composition of the proposed study population will reflect that of subjects recruited through the Longitudinal Cohort of the Massachusetts Alzheimer's Disease Research Center and that of patients treated by neurologists at the Memory and Movement Disorders Clinics at MGH as well as participants from the community.
Age-matched Controls	AROMHA Brain Health Test	We will utilize community sampling to recruit 100 age-matched controls.

Primary Outcome Measures

Name	Time	Method
AROMHA Brain Health Test	1 hour	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.

Secondary Outcome Measures

Name	Time	Method
AROMHA Brain Health Test	1 hour	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States