Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05881239

Conditions

Subjective Cognitive Concerns

Mild Cognitive Impairment

Mild Behavioral Impairment

Healthy Aging

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

AROMHA Brain Health Test

Study Details

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 ID

NCT05881239

Start date

May 9, 2023

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Age-matched Controls

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

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.

Primary outcome measure

  • AROMHA Brain Health Test [ Time Frame: 1 hour ]

Central Contacts and Locations

Central contacts

Mark W Albers, MD PhD

617-724-7401albers.mark@mgh.harvard.edu

Alefiya Albers, PhD

AALBERS@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Mark W Albers, MD PhD

617-724-7401albers.mark@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • Alzheimer's disease
  • Olfactory
  • Neurodegeneration
  • Mild Cognitive Impairment
  • Mild Behavioral Impairment
  • Subjective Cognitive Concerns
  • Olfactory dysfunction
  • Biomarker
  • Cognitive Assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-06.