Mild Cognitive Impairment (MCI)ASCANCT06789094
Validating the Ain Shams Cognitive Assessment Tool
An observational study of Mild Cognitive Impairment (MCI) and Dementia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The diagnosis of cognitive impairment, including dementia and mild cognitive impairment (MCI), is crucial for timely intervention and management. Various screening tools are available for assessing cognitive function, among which the Mini-Mental State Examination (MMSE), the Addenbrooke's Cognitive Examination (ACE)… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Dementia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Jun 2025
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community dwelling elderly participants (caregivers of inpatients, attendants of primary care , elderly clubs and other community gatherings).
Who may be able to join
None listed.
Who cannot join
- severe dementia, delirium, major mental disorders, aphasia, and those with severe visual or hearing impairment that interfere with the assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validating the Ain Shams Cognitive Assessment (ASCA) for Diagnosing Mild Cognitive Impairment and Dementia
The diagnosis of cognitive impairment, including dementia and mild cognitive impairment (MCI), is crucial for timely intervention and management. Various screening tools are available for assessing cognitive function, among which the Mini-Mental State Examination (MMSE), the Addenbrooke's Cognitive Examination (ACE), and the Montreal Cognitive Assessment (MoCA) are widely used. However, the recently developed Ain Shams University Cognitive Assessment (ASCA) has shown promise in detecting early cognitive decline. This study aims to assess the performance of ASCA in diagnosing cognitive impairment against DSM5 criteria.
- Conditions
- Mild Cognitive Impairment (MCI), Dementia
- Being tested
- Ain Shams University Cognitive Assessment (ASCA) tool
- Keywords
- Mild cognitive impairment, Dementia, cognitive assessment, Arabic cognitive assessment tools
- 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.
Ain Shams University Cognitive Assessment (ASCA) toolOther
Also called Patient Health Questionnaire 9, activity of daily living questionnaire
The ASCA, developed at Ain Shams University, is a comprehensive tool designed for cognitive assessment in Egyptian population. It encompasses various tests to assess cognitive functions and cultural understanding. These include the Verbal Paired Associated Test, evaluating verbal learning, distractor interval, delayed recall, and word recognition. The Bender Gestalt assesses visual-motor skills and memory. Short-term and working memory are tested through Digit Forward and Digit Backward Span Length tasks. Set Shifting is measured using a modified Trail Making Test, adapted for illiterates. Additionally, tests for letter/lexical fluency, verbal fluency, language object naming, abstraction, and judgment offer further insights into cognitive abilities and cultural interpretation.
| Study group | Role | What they receive |
|---|---|---|
| Dementia | participants >60 years with Dementia diagnosed by DSM-5 criteria Receives: Other: Ain Shams University Cognitive Assessment (ASCA) tool | |
| Mild cognitive impairment | participants >60 years with Mild cognitive impairment (MCI) diagnosed by DSM-5 criteria Receives: Other: Ain Shams University Cognitive Assessment (ASCA) tool | |
| control | euthymic healthy community dwelling adult participants of various socioeconomic and educational status. Receives: Other: Ain Shams University Cognitive Assessment (ASCA) tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASCA cut off points
obtain cut-off scores for diagnosing mild cognitive impairment (MCI) and dementia using the Ain Shams Cognitive Assessment
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Rasheedy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789094
- Sponsor's protocol ID
- FMASU R310/2024
- Acronym
- ASCA
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Ain Shams Cognitive Assessment (ASCA) for Diagnosing Mild Cognitive Impairment and Dementia
- ClinicalTrials.gov ID
- NCT06789094
- Acronym / sponsor ID
- ASCA / FMASU R310/2024
- Conditions
- Mild Cognitive Impairment (MCI), Dementia
- Keywords
- Mild cognitive impairment, Dementia, cognitive assessment, Arabic cognitive assessment tools
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 Jan 2025 (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 diagnosis of cognitive impairment, including dementia and mild cognitive impairment (MCI), is crucial for timely intervention and management. Various screening tools are available for assessing cognitive function, among which the Mini-Mental State Examination (MMSE), the Addenbrooke's Cognitive Examination (ACE), and the Montreal Cognitive Assessment (MoCA) are widely used. However, the recently developed Ain Shams University Cognitive Assessment (ASCA) has shown promise in detecting early cognitive decline. This study aims to assess the performance of ASCA in diagnosing cognitive impairment against DSM5 criteria.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dementia | – | Other: Ain Shams University Cognitive Assessment (ASCA) toolparticipants >60 years with Dementia diagnosed by DSM-5 criteria |
| Mild cognitive impairment | – | Other: Ain Shams University Cognitive Assessment (ASCA) toolparticipants >60 years with Mild cognitive impairment (MCI) diagnosed by DSM-5 criteria |
| control | – | Other: Ain Shams University Cognitive Assessment (ASCA) tooleuthymic healthy community dwelling adult participants of various socioeconomic and educational status. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community dwelling elderly participants (caregivers of inpatients, attendants of primary care , elderly clubs and other community gatherings).
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- severe dementia, delirium, major mental disorders, aphasia, and those with severe visual or hearing impairment that interfere with the assessment.
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 |
|---|---|---|
| Ain Shams University Cognitive Assessment (ASCA) toolAlso: Patient Health Questionnaire 9, activity of daily living questionnaireThe ASCA, developed at Ain Shams University, is a comprehensive tool designed for cognitive assessment in Egyptian population. It encompasses various tests to assess cognitive functions and cultural understanding. These include the Verbal Paired Associated Test, evaluating verbal learning, distractor interval, delayed recall, and word recognition. The Bender Gestalt assesses visual-motor skills and memory. Short-term and working memory are tested through Digit Forward and Digit Backward Span Length tasks. Set Shifting is measured using a modified Trail Making Test, adapted for illiterates. Additionally, tests for letter/lexical fluency, verbal fluency, language object naming, abstraction, and judgment offer further insights into cognitive abilities and cultural interpretation. | Other | Dementia, Mild cognitive impairment, control |
Primary outcome
ASCA cut off points
Time frame: 4 months
obtain cut-off scores for diagnosing mild cognitive impairment (MCI) and dementia using the Ain Shams Cognitive Assessment
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 23 Jan 2025.
- 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.
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 (MCI) and Dementia, run by Ain Shams University at 1 site in Egypt.
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 0 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: opening soon, as of the sponsor's last update on 23 Jan 2025. 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 Egypt. 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 Doha Rasheedy, Professor (01001193544 ext. 202, doharasheedy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASCA cut off points (time frame: 4 months). 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 Jan 2025.