Alzheimer DiseaseNCT05449626
Validity and Reliability of Turkish Version of Bayer Activities of Daily Living Scale
An observational study of Alzheimer Disease and Activities of Daily Living, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to verify the validity and reliability of the Turkish version of B-GYA. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Activities of Daily Living
- What is being tested?
- Assessment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2022to 6 Jan 2023
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to verify the validity and reliability of the Turkish version of B-GYA.
Read the detailed description
Dementia refers to a condition in which individuals with brain damage have multiple cognitive deficits with impairment in activities of daily living (ADL). Therefore, the assessment of ADL is one of the main criteria for evaluating dementia. ADL disorders are often observed by caregivers before they are identified by psychometric testing, thus suggesting that ADL assessment can contribute to the early detection of dementia.
Evaluation of ADL has become increasingly important with the introduction of new drugs for Alzheimer's disease (AD), as well as being a helpful tool in diagnosis. Current guidelines have recognized the need for therapeutic intervention in AD to measure and document treatment effects on ADL. It has been emphasized that internationally validated and approved test tools to evaluate dementia are important for multinational clinical drug trials that evaluate the efficacy of anti-dementia drugs. Therefore, it is of great importance to find ADL scales that can be used internationally. Various ADL scales have been developed, such as Lawton's instrumental ADL (IADL), functional activities questionnaire (FAQ), ADCS-ADL, and Bayer ADL (B-ADL). Of these, W-ADL was developed based on an international pilot study to evaluate ADL deficits in patients from different cultural backgrounds.
Specifically, through a collaborative study conducted in four different countries during the development of the RDA, the researchers prepared 141 items and selected 25 of them that could be used internationally. The target group of the scale included elderly patients suffering from mild to moderate dementia or cognitive impairment. European countries: In the United Kingdom, Germany, and Spain, the validation study of the B-ADL was carried out in three stages. The aim of our research is to verify the validity and reliability of the Turkish version of B-ADL.
- Conditions
- Alzheimer Disease, Activities of Daily Living
- Being tested
- Assessment
- Keywords
- Alzheimer's disease, Activities of Daily Living
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease group | Not described Receives: Diagnostic Test: Assessment | |
| Healthy Group | Not described Receives: Diagnostic Test: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start26 Jul 2022
- Primary completion6 Oct 2022
- Study completion6 Jan 2023
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449626
- Sponsor's protocol ID
- 2022/514/227/3
- Status last verified
- Jun 2023
- First submitted
- 4 Jul 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- 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 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Turkish Version of Bayer Activities of Daily Living Scale
- ClinicalTrials.gov ID
- NCT05449626
- Acronym / sponsor ID
- 2022/514/227/3
- Conditions
- Alzheimer Disease, Activities of Daily Living
- Keywords
- Alzheimer's disease, Activities of Daily Living
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 8 Jul 2022 (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 aim of our study is to verify the validity and reliability of the Turkish version of B-GYA.
Detailed description
Dementia refers to a condition in which individuals with brain damage have multiple cognitive deficits with impairment in activities of daily living (ADL). Therefore, the assessment of ADL is one of the main criteria for evaluating dementia. ADL disorders are often observed by caregivers before they are identified by psychometric testing, thus suggesting that ADL assessment can contribute to the early detection of dementia.
Evaluation of ADL has become increasingly important with the introduction of new drugs for Alzheimer's disease (AD), as well as being a helpful tool in diagnosis. Current guidelines have recognized the need for therapeutic intervention in AD to measure and document treatment effects on ADL. It has been emphasized that internationally validated and approved test tools to evaluate dementia are important for multinational clinical drug trials that evaluate the efficacy of anti-dementia drugs. Therefore, it is of great importance to find ADL scales that can be used internationally. Various ADL scales have been developed, such as Lawton's instrumental ADL (IADL), functional activities questionnaire (FAQ), ADCS-ADL, and Bayer ADL (B-ADL). Of these, W-ADL was developed based on an international pilot study to evaluate ADL deficits in patients from different cultural backgrounds.
Specifically, through a collaborative study conducted in four different countries during the development of the RDA, the researchers prepared 141 items and selected 25 of them that could be used internationally. The target group of the scale included elderly patients suffering from mild to moderate dementia or cognitive impairment. European countries: In the United Kingdom, Germany, and Spain, the validation study of the B-ADL was carried out in three stages. The aim of our research is to verify the validity and reliability of the Turkish version of B-ADL.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease group | – | Diagnostic Test: Assessment |
| Healthy Group | – | Diagnostic Test: Assessment |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| AssessmentThe 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. | Diagnostic test | Alzheimer's disease group, Healthy Group |
Primary outcome
Standardized Mini Mental Test
Time frame: Up to 6 months
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.
Clinical Dementia Rating Scale
Time frame: Up to 6 months
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.
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 3 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Activities of Daily Living, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 3 Jul 2023. 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 Turkey (Türkiye). 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?
Standardized Mini Mental Test (time frame: Up to 6 months). The study lists 2 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 3 Jul 2023.