NCT06789094

Brief 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), 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 17, 2025

Last Update Submit

January 17, 2025

Conditions

Keywords

Mild cognitive impairmentDementiacognitive assessmentArabic cognitive assessment tools

Outcome Measures

Primary Outcomes (1)

  • ASCA cut off points

    obtain cut-off scores for diagnosing mild cognitive impairment (MCI) and dementia using the Ain Shams Cognitive Assessment

    4 months

Study Arms (3)

Dementia

participants \>60 years with Dementia diagnosed by DSM-5 criteria

Other: Ain Shams University Cognitive Assessment (ASCA) tool

Mild cognitive impairment

participants \>60 years with Mild cognitive impairment (MCI) diagnosed by DSM-5 criteria

Other: Ain Shams University Cognitive Assessment (ASCA) tool

control

euthymic healthy community dwelling adult participants of various socioeconomic and educational status.

Other: Ain Shams University Cognitive Assessment (ASCA) tool

Interventions

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.

Also known as: Patient Health Questionnaire 9, activity of daily living questionnaire
DementiaMild cognitive impairmentcontrol

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community dwelling elderly participants (caregivers of inpatients, attendants of primary care , elderly clubs and other community gatherings).

You may not qualify if:

  • severe dementia, delirium, major mental disorders, aphasia, and those with severe visual or hearing impairment that interfere with the assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Interventions

Equipment and SuppliesPatient Health Questionnaire

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Doha Rasheedy, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Geriatrics and Gerontology

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

February 1, 2025

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

January 23, 2025

Record last verified: 2025-01

Locations