Subjective Cognitive ConcernsNCT05881239
Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD
An observational study of Subjective Cognitive Concerns and Mild Cognitive Impairment, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Concerns, Mild Cognitive Impairment, Mild Behavioral Impairment
- What is being tested?
- AROMHA Brain Health Test
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Subjective Cognitive Concerns (SCC), 2. Mild Cognitive Impairment, 3. Mild Behavioral Impairment, 4. Healthy Age-matched Controls.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alefiya Albers, PhD contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02129
Mark W Albers, MD PhD, 617-724-7401, albers.mark@mgh.harvard.edu
About this study
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.
- Conditions
- Subjective Cognitive Concerns, Mild Cognitive Impairment, Mild Behavioral Impairment, Healthy Aging
- Being tested
- AROMHA Brain Health Test
- Keywords
- Alzheimer's disease, Olfactory, Neurodegeneration, Mild Cognitive Impairment, Mild Behavioral Impairment, Subjective Cognitive Concerns, Olfactory dysfunction, Biomarker, Cognitive Assessment
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Anosmia, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AROMHA Brain Health TestDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AROMHA Brain Health Test | |
| 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. Receives: Device: AROMHA Brain Health Test | |
| 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. Receives: Device: AROMHA Brain Health Test | |
| Age-matched Controls | We will utilize community sampling to recruit 100 age-matched controls. Receives: Device: AROMHA Brain Health Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
AROMHA Brain Health Test
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.
Measured: 1 hour
Secondary outcomes (1)
AROMHA Brain Health Test
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 MBI patients' performance against age-matched controls.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start9 May 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive ConcernsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark W Albers, Massachusetts General Hospital
- Investigators
- Mark W Albers, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881239
- Sponsor's protocol ID
- 2022P002451
- Status last verified
- Mar 2026
- First submitted
- 19 May 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD
- ClinicalTrials.gov ID
- NCT05881239
- Acronym / sponsor ID
- 2022P002451
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjective Cognitive Concerns (SCC) | – | Device: AROMHA Brain Health TestThe 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. |
| Mild Cognitive Impairment (MCI) | – | Device: AROMHA Brain Health TestThe 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. |
| Mild Behavioral Impairment [prominent apathy] (MBI) | – | Device: AROMHA Brain Health TestThe 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. |
| Age-matched Controls | – | Device: AROMHA Brain Health TestWe will utilize community sampling to recruit 100 age-matched controls. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Subjective Cognitive Concerns (SCC), 2. Mild Cognitive Impairment, 3. Mild Behavioral Impairment, 4. Healthy Age-matched Controls.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AROMHA Brain Health TestThe 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. | Device | Age-matched Controls, Mild Behavioral Impairment [prominent apathy] (MBI), Mild Cognitive Impairment (MCI), Subjective Cognitive Concerns (SCC) |
Primary outcome
AROMHA Brain Health Test
Time frame: 1 hour
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.
1 secondary outcome
AROMHA Brain Health Test
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory Concerns
Subjective Cognitive Decline, Alzheimer Disease
RecruitingObservational study
The Signature of Alzheimer's Disease in Subjective Cognitive Decline
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alefiya Albers, PhD contact
Mark W Albers, MD PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjective Cognitive Concerns and Mild Cognitive Impairment, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark W Albers, MD PhD (617-724-7401, albers.mark@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AROMHA Brain Health Test (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.