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NCT05881239 · ClinicalTrials.gov registry record
Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD
A clinical trial of Mild Cognitive Impairment and Healthy Aging, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- 250
- Enrollment target
- 1
- Study location
NCT05881239: Recruiting study of Mild Cognitive Impairment and Healthy Aging, sponsored by Massachusetts General Hospital.
NCT05881239 is a study of Mild Cognitive Impairment and Healthy Aging that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 250 participants, below the 1,269-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05881239, a study of Mild Cognitive Impairment and Healthy Aging, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE AROMHA Brain Health Test
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2023-05-09 |
| Est. Completion | 2027-12-31 |
What NCT05881239 shows while recruiting
NCT05881239 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,269-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (80% lower).
The record links to 4 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 1 intervention - of which AROMHA Brain Health Test is the first listed.
NCT05881239 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05881239 about?
NCT05881239 is a clinical study titled "Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD". 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 Healt...
What is the current status of trial NCT05881239?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2023-05-09. Estimated completion is 2027-12-31.
What conditions does trial NCT05881239 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Healthy Aging, Subjective Cognitive Concerns, Mild Behavioral Impairment.
What interventions are being tested in trial NCT05881239?
The interventions under investigation include: AROMHA Brain Health Test (DEVICE).
Who is sponsoring clinical trial NCT05881239?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05881239 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05881239's enrollment target sits among peer trials
250 35th of 205 higher than 170 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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