Developing an Artificial Intelligence System to Detect Cognitive Impairment

Alzheimer Disease Clinical Trial

Official title:

Developing an Artificial Intelligence System to Detect Mild Cognitive Impairment and Alzheimer's Disease Dementia Through Self-Figure Drawing: An Innovative Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794451
• Other study ID #: ALZAI
• Status: Recruiting
• Start date: March 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: University of Haifa
• Contact: Amit Perry, MA
• Phone: +9722454258
• Email: peryamit1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Healthy Aging
• Mild Cognitive Impairment

Locations

Country	Name	City	State
Israel	University of Haifa	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Technion, Israel Institute of Technology

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One day
Primary	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").	One day
Primary	Self-figure drawing -Cognition	Self-figure drawing. Participants will be asked to draw themselves using a pencil on an A4-sized sheet of paper.	One day