Mild Cognitive Impairment and DementiaNCT05534958
UK Validation of the Automated "AcceXible" Speech Analysis Software
An observational study of Mild Cognitive Impairment and Dementia, run by Accexible at 1 site in United Kingdom.
Trial summary
Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment and Dementia
- What is being tested?
- Accexible
- Type of treatment
- Medical device
- How many people
- 221 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 to 90 years
- All sexes
- Adult, Older adult
Study population: Sample: Cases: 125 adult patients >55 years with suspected MCI or diagnosis of dementia referred to memory clinic. Controls: 125 healthy adult patients >55 years without a diagnosis of MCI and without subjective cognitive complaints.
Who may be able to join
- Adult patients 55+ years of age with suspected MCI or diagnosis of dementia referred into secondary care memory clinic by their General Practitioner.
- Have English as first language (able to speak and understand verbal messages).
- Patients must have agreed to participate in the study and have voluntarily signed the informed consent.
- Healthy older adults (55+ years of age), without a diagnosis neurological, or psychiatric disorders or any clinical evidence of cognitive decline.
- Have English as first language (able to speak and understand verbal messages).
- Controls must have agreed to participate in the study and have voluntarily signed the informed consent.
Who cannot join
- To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.
- To have significant vision problems that would affect the ability to perceive visual stimuli.
- To have significant hearing problems that would affect the ability to understand verbal cues.
- To be unable to give informed consent to participate in the study.
- Objective evidence of significant cognitive decline in any one domain.
- Score of <88 on ACE-III cognitive testing.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cornwall Partnership NHS Foundation Trust
Cornwell
About this study
Official title: Assessing the Diagnostic Accuracy of a Three One-minute Tests of Verbal Fluency, Using Artificial Intelligence, in Detecting Mild Cognitive Impairment and Early Dementia.
Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. The sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration.
A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.
The present study has the objective of validating a digital method for detection and follow-up of patients with mild cognitive impairment (MCI) or dementia in a memory clinic setting.
- Conditions
- Mild Cognitive Impairment and Dementia
- Being tested
- Accexible
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccexibleDevice
Speech Analysis
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Not described Receives: Device: Accexible | |
| Mild Cognitive Impairment | Not described Receives: Device: Accexible | |
| Early Dementia | Not described Receives: Device: Accexible |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of Accexible's digital screening battery
Measure the odds that a patient has MCI or dementia measured by vocal biomarkers
Measured: An average of 1 year
Secondary outcomes (1)
Correlation of Accexible's test battery with the ACE III
Comparison of Accexible's test battery with ACE III diagnostic predictive value at various cut-off points (e.g. 82 and 88 for ACE III)
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start18 Nov 2022
- Primary completion12 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment and DementiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accexible
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cornwall Partnership NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534958
- Sponsor's protocol ID
- 22/PR/0963
- Status last verified
- Apr 2026
- First submitted
- 7 Sep 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Diagnostic Accuracy of a Three One-minute Tests of Verbal Fluency, Using Artificial Intelligence, in Detecting Mild Cognitive Impairment and Early Dementia.
- ClinicalTrials.gov ID
- NCT05534958
- Acronym / sponsor ID
- 22/PR/0963
- Conditions
- Mild Cognitive Impairment and Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- AccexibleIndustry (pharma, biotech, devices)
- Collaborators
- Cornwall Partnership NHS Foundation Trust
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Sep 2022 (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.
Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. The sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration.
A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.
The present study has the objective of validating a digital method for detection and follow-up of patients with mild cognitive impairment (MCI) or dementia in a memory clinic setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Device: Accexible |
| Mild Cognitive Impairment | – | Device: Accexible |
| Early Dementia | – | Device: Accexible |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Sample: Cases: 125 adult patients >55 years with suspected MCI or diagnosis of dementia referred to memory clinic. Controls: 125 healthy adult patients >55 years without a diagnosis of MCI and without subjective cognitive complaints.
Key inclusion criteria (6 listed)
- Adult patients 55+ years of age with suspected MCI or diagnosis of dementia referred into secondary care memory clinic by their General Practitioner.
- Have English as first language (able to speak and understand verbal messages).
- Patients must have agreed to participate in the study and have voluntarily signed the informed consent.
- Healthy older adults (55+ years of age), without a diagnosis neurological, or psychiatric disorders or any clinical evidence of cognitive decline.
- Have English as first language (able to speak and understand verbal messages).
Key exclusion criteria (6 listed)
- To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.
- To have significant vision problems that would affect the ability to perceive visual stimuli.
- To have significant hearing problems that would affect the ability to understand verbal cues.
- To be unable to give informed consent to participate in the study.
- Objective evidence of significant cognitive decline in any one domain.
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 |
|---|---|---|
| AccexibleSpeech Analysis | Device | Early Dementia, Healthy, Mild Cognitive Impairment |
Primary outcome
Diagnostic performance of Accexible's digital screening battery
Time frame: An average of 1 year
Measure the odds that a patient has MCI or dementia measured by vocal biomarkers
1 secondary outcome
Correlation of Accexible's test battery with the ACE III
Time frame: An average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Mild Cognitive Impairment and Dementia, run by Accexible at 1 site in United Kingdom.
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 6 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: finished, as of the sponsor's last update on 23 Apr 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of Accexible's digital screening battery (time frame: An average of 1 year). 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 23 Apr 2026.