Alzheimer DiseaseNCT05794451
Developing an Artificial Intelligence System to Detect Cognitive Impairment
An observational study of Alzheimer Disease and Healthy Aging, run by University of Haifa at 1 site in Israel.
Trial summary
Alzheimer's disease dementia (AD) is a debilitating and prevalent neurodegenerative disease in older adults globally. Cognitive impairment, a hallmark of AD, is assessed through verbal tests that require high specialization, and while accepted as screening tools for AD, general practitioners seldom use them. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Healthy Aging, Mild Cognitive Impairment
- How many people
- 3,413 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Mar 2023to 31 Mar 2026
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 60 or above, who live in Israel.
Who may be able to join
- Adults aged 60 and above with subtle signs of risk of future cognitive decline, residing in the community or in nursing homes with a minimum of 10 years of education.
Who cannot join
- Current or past psychiatric illness, the presence of congenital/organic cognitive condition, severe visual or motor impairment, and terminal illness (to avoid the effect of comorbidities).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing an Artificial Intelligence System to Detect Mild Cognitive Impairment and Alzheimer's Disease Dementia Through Self-Figure Drawing: An Innovative Approach
Alzheimer's disease dementia (AD) is a debilitating and prevalent neurodegenerative disease in older adults globally. Cognitive impairment, a hallmark of AD, is assessed through verbal tests that require high specialization, and while accepted as screening tools for AD, general practitioners seldom use them. AD can be diagnosed with expensive, invasive neuroimaging and blood tests, but these are usually conducted when cognitive functioning is already severely impaired. Thus, finding a novel, non-invasive tool to detect and differentiate mild cognitive impairment (MCI) and AD is a prime public health interest. Self-figure drawings (a projective tool in which individuals are asked to draw a picture of themselves), are easy to administer and have been shown to differentiate between healthy and cognitively impaired individuals, including AD. Convolutional Neural Network (CNN) (a type of deep neural network, applied to analyze visual imagery) has advanced to assess health conditions using art products. Therefore, the proposed study suggests utilizing CNN-based methods to develop and test an application tailored to differentiate between drawings of individuals with MCI, AD, and healthy controls (HC) using 4,000 self-figure drawings. This
- Conditions
- Alzheimer Disease, Healthy Aging, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Adults aged 60 and above without cognitive impairment | |
| Mild cognitive impairment | Adults 60 and above with mild cognitive impairment | |
| Alzheimer's disease | Adults diagnosed with Alzheimer's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
The Montreal Cognitive Assessment (MoCA) is a 10-minute paper-based test that aims to detect MCI in older patients with symptomatology, suggesting impaired cognition. The MoCA is composed of 12 tasks to detect short-term memory, visuospatial ability, executive functioning, phonemic fluency, abstraction, attention, concentration, working memory, language, and orientation.
Measured: One day
Cognition for adults diagnosed with Alzheimer's disease
The Self-reported Cognitive Difficulties (CDS)75 is a 39-item questionnaire that requires participants or their caregivers in case of AD to rate how often they currently experience cognitive difficulties in everyday life using a 5-point scale (0 -"never" to 4 -"very often").
Measured: One day
Self-figure drawing -Cognition
Self-figure drawing. Participants will be asked to draw themselves using a pencil on an A4-sized sheet of paper.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start20 Mar 2023
- Primary completion31 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Cross-sectional
- Enrolment
- 3,413 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, Johanna Czamanski-Cohen, University of Haifa
- Investigators
- Johanna Czamanski-Cohen, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794451
- Sponsor's protocol ID
- ALZAI
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an artificial intelligence study, thus there will not be a dataset available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Artificial Intelligence System to Detect Mild Cognitive Impairment and Alzheimer's Disease Dementia Through Self-Figure Drawing: An Innovative Approach
- ClinicalTrials.gov ID
- NCT05794451
- Acronym / sponsor ID
- ALZAI
- Conditions
- Alzheimer Disease, Healthy Aging, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,413 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 3 Apr 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.
Alzheimer's disease dementia (AD) is a debilitating and prevalent neurodegenerative disease in older adults globally. Cognitive impairment, a hallmark of AD, is assessed through verbal tests that require high specialization, and while accepted as screening tools for AD, general practitioners seldom use them. AD can be diagnosed with expensive, invasive neuroimaging and blood tests, but these are usually conducted when cognitive functioning is already severely impaired. Thus, finding a novel, non-invasive tool to detect and differentiate mild cognitive impairment (MCI) and AD is a prime public health interest. Self-figure drawings (a projective tool in which individuals are asked to draw a picture of themselves), are easy to administer and have been shown to differentiate between healthy and cognitively impaired individuals, including AD. Convolutional Neural Network (CNN) (a type of deep neural network, applied to analyze visual imagery) has advanced to assess health conditions using art products. Therefore, the proposed study suggests utilizing CNN-based methods to develop and test an application tailored to differentiate between drawings of individuals with MCI, AD, and healthy controls (HC) using 4,000 self-figure drawings. This
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –Adults aged 60 and above without cognitive impairment |
| Mild cognitive impairment | – | –Adults 60 and above with mild cognitive impairment |
| Alzheimer's disease | – | –Adults diagnosed with Alzheimer's disease |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 60 or above, who live in Israel.
Key inclusion criteria (1 listed)
- Adults aged 60 and above with subtle signs of risk of future cognitive decline, residing in the community or in nursing homes with a minimum of 10 years of education.
Key exclusion criteria (1 listed)
- Current or past psychiatric illness, the presence of congenital/organic cognitive condition, severe visual or motor impairment, and terminal illness (to avoid the effect of comorbidities).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognition
Time frame: One day
The Montreal Cognitive Assessment (MoCA) is a 10-minute paper-based test that aims to detect MCI in older patients with symptomatology, suggesting impaired cognition. The MoCA is composed of 12 tasks to detect short-term memory, visuospatial ability, executive functioning, phonemic fluency, abstraction, attention, concentration, working memory, language, and orientation.
Cognition for adults diagnosed with Alzheimer's disease
Time frame: One day
The Self-reported Cognitive Difficulties (CDS)75 is a 39-item questionnaire that requires participants or their caregivers in case of AD to rate how often they currently experience cognitive difficulties in everyday life using a 5-point scale (0 -"never" to 4 -"very often").
Self-figure drawing -Cognition
Time frame: One day
Self-figure drawing. Participants will be asked to draw themselves using a pencil on an A4-sized sheet of paper.
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 4 May 2026.
- Individual participant dataSharing planned: No. This is an artificial intelligence study, thus there will not be a dataset available for sharing.
Related trials for Alzheimer Disease
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
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.
Johanna Czamanski-Cohen, PhD principal investigator
University of Haifa
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 Alzheimer Disease and Healthy Aging, run by University of Haifa at 1 site in Israel.
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 1 inclusion and 1 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 4 May 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 Israel. 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?
Cognition (time frame: One day). The study lists 3 primary outcomes in all. 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 4 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.