Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AROMHA Brain Health Test.
- Who it may be relevant to
- Registry conditions: Subjective Cognitive Concerns, Mild Cognitive Impairment, Mild Behavioral Impairment, Healthy Aging. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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 incl
Primary outcome measures
- AROMHA Brain Health Test [Time frame: 1 hour]
Secondary outcome measures (1)
- AROMHA Brain Health Test [Time frame: 1 hour]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT05881239 · 2022P002451