NCT05449626

Brief Summary

The aim of our study is to verify the validity and reliability of the Turkish version of B-GYA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

July 26, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

July 4, 2022

Last Update Submit

June 30, 2023

Conditions

Keywords

Alzheimer's diseaseActivities of Daily Living

Outcome Measures

Primary Outcomes (2)

  • Standardized Mini Mental Test

    For the first time, Folstein et al. \[12\] and found to be valid and reliable in the diagnosis of mild dementia in the Turkish population will be used. SMMT, which measures mental state, is a scale that evaluates cognitive functions in five separate sections (orientation, registration, attention and calculation, recall and language). The test can be easily applied in daily medical practice and is very suitable for screening cognitive function in the elderly. The total score is 30. The cut-off point of the scale was determined as 24.

    Up to 6 months

  • Clinical Dementia Rating Scale

    The Clinical Dementia Rating Scale was developed by Woolf in 2016 in order to have information about the participant's memory, orientation, judgment and problem-solving ability, functionality outside the home, home life, hobbies and personal care. An evaluation will be made by asking detailed questions about all the areas specified in this test, which will be applied to the patient and their relatives. According to the answers given in each field, it will be scored as 0-0.5-1-2-3 by using the score table in the front of the test. It is a general assessment made to determine the dementia stage of the person. 0.5-1 mild, 1-2 moderate, 2-3 advanced stages of dementia.

    Up to 6 months

Study Arms (2)

Alzheimer's disease group

Diagnostic Test: Assessment

Healthy Group

Diagnostic Test: Assessment

Interventions

AssessmentDIAGNOSTIC_TEST

The Standardized Mini-Mental Test and Clinical Dementia Rating Scale will be administered by the physician to the healthy individuals with dementia to be included in the study.

Alzheimer's disease groupHealthy Group

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

200 individuals and healthy individuals who were diagnosed with Alzheimer's according to the international diagnostic criteria of the American National Neurological and Communication Disorders Stroke and Alzheimer Association (NINCDS-ADRDA) and were in mild and moderate stages (\<2) according to the Clinical Dementia Rating: CDR. 200 individuals found will be included

You may qualify if:

  • Individuals aged 60 and over
  • Being literate
  • Having given consent to participate in the study
  • Individuals diagnosed with Alzheimer's according to the international diagnostic criteria of the American National Neurological and Communication Disorders Stroke and Alzheimer's Association (NINCDS-ADRDA) and in mild and moderate stages (\<2) according to the Clinical Dementia Rating: CDR will be included in the study.

You may not qualify if:

  • Those who did not give consent to participate in the study
  • CDR\>2
  • Except for behavioral or functional symptoms associated with dementia, individuals with medical, psychiatric, neurological conditions, or physical disabilities that may significantly affect the performance of ADL will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Turkiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 8, 2022

Study Start

July 26, 2022

Primary Completion

October 6, 2022

Study Completion

January 6, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations