Clinical trial NCT05881239: Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD
Official title: Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


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).

Primary outcomes:
measure: AROMHA Brain Health Test
timeFrame: 1 hour
Secondary outcomes:
measure: AROMHA Brain Health Test
timeFrame: 1 hour
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Mark W Albers, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: