Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

NCT05881239 | Recruiting

• 1 other identifier: 2022P002451
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• AROMHA Brain Health Test

  1 hour

Study Arms (4)

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

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

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

Age-matched Controls

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

Device: AROMHA Brain Health Test

Interventions

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.

Age-matched Controls; Mild Behavioral Impairment [prominent apathy] (MBI); Mild Cognitive Impairment (MCI); Subjective Cognitive Concerns (SCC)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Primary pulmonary disease such as severe emphysema or asthma not under good medical control.
• Current sinusitis, common cold, upper respiratory infection, or nasal polyps.
• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Anosmia; Nerve Degeneration

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Mark W Albers, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark W Albers, MD PhD

CONTACT

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

Alefiya Albers, PhD

CONTACT

AALBERS@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Frank Wilkens and Family Endowed Scholar/ Asst. Prof. Neurology

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: May 9, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)