Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

Mass General Brigham

Status: Enrolling

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

Treatments: Device: AROMHA Brain Health Test

Study type: Observational

Funder types: Other

Identifiers

NCT05881239

2022P002451

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

250 participants in 4 patient groups

Subjective Cognitive Concerns (SCC)

Description:

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.

Treatment:

Device: AROMHA Brain Health Test

Mild Cognitive Impairment (MCI)

Description:

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.

Treatment:

Device: AROMHA Brain Health Test

Mild Behavioral Impairment [prominent apathy] (MBI)

Description:

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.

Treatment:

Device: AROMHA Brain Health Test

Age-matched Controls

Description:

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

Treatment:

Device: AROMHA Brain Health Test