Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Aging; Mild Cognitive Impairment; Subjective Cognitive Concerns; Mild Behavioral Impairment
• Intervention / Treatment: Device: AROMHA Brain Health Test

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Mark W Albers, MD PhD; Phone Number: 617-724-7401; Email: albers.mark@mgh.harvard.edu
• Study Contact Backup: Name: Alefiya Albers, PhD; Email: AALBERS@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Mark W Albers, MD PhD; Phone Number: 617-724-7401; Email: albers.mark@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjective Cognitive Concerns (SCC); 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.	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.
Mild Cognitive Impairment (MCI); 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.	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.
Mild Behavioral Impairment [prominent apathy] (MBI); 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.	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.
Age-matched Controls; We will utilize community sampling to recruit 100 age-matched controls.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Mark W Albers, MD PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Biomarker; Alzheimer's disease; Mild Cognitive Impairment; Neurodegeneration; Olfactory dysfunction; Cognitive Assessment; Olfactory; Mild Behavioral Impairment; Subjective Cognitive Concerns
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2022P002451

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No