Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

NCT ID: NCT05881239

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2025-08-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

AROMHA Brain Health Test

Intervention Type: 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.

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.

AROMHA Brain Health Test

Intervention Type: 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.

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.

AROMHA Brain Health Test

Intervention Type: 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.

Age-matched Controls

We will utilize community sampling to recruit 100 age-matched controls.

AROMHA Brain Health Test

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mark W Albers

Frank Wilkens and Family Endowed Scholar/ Asst. Prof. Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark W Albers, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark W Albers, MD PhD

Role: CONTACT

albers.mark@mgh.harvard.edu

617-724-7401

Alefiya Albers, PhD

Role: CONTACT

AALBERS@mgh.harvard.edu

Facility Contacts

Mark W Albers, MD PhD

Role: primary

albers.mark@mgh.harvard.edu

617-724-7401

Other Identifiers

2022P002451

Identifier Type: -

Identifier Source: org_study_id