Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05881239
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Aging
  • Mild Behavioral Impairment
  • Mild Cognitive Impairment
  • Subjective Cognitive Concerns

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
May 9, 2023
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: Age-matched Controls
    We will utilize community sampling to recruit 100 age-matched controls.

Primary Outcome Measure

AROMHA Brain Health Test [ Time Frame: 1 hour ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02129
Mark W Albers, MD PhD
[email protected]
617-724-7401

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

Related Studies