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NCT Number: NCT05881239

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.

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Key information

Conditions

Subjective Cognitive Concerns Alzheimer Disease Anosmia Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Healthy Aging Mental Disorders Mild Behavioral Impairment Mild Cognitive Impairment Nerve Degeneration Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Olfaction Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tauopathies

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location status: Recruiting

Location contact

Mark W Albers, MD PhD

CONTACT

[email protected]

617-724-7401

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

AROMHA Brain Health Test

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.

Primary outcomes

  1. AROMHA Brain Health Test

    Time frame: 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 outcomes

  1. AROMHA Brain Health Test

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alefiya Albers, PhD

CONTACT

[email protected]

Mark W Albers, MD PhD

CONTACT

[email protected]

617-724-7401

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 31, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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