- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06365658
Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective
Cognitive Functioning Profiles in Adults With Neurologically Recognized Aphasic Syndromes and General Population From a Biopsychosocial Perspective
The goal of this observational study is to investigate cognitive functioning profiles in adults with neurologically recognized aphasic syndromes and general population.
The study group consist of minimal 600 adults (over 18 y.o.) who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: memory, learning and language. Furthermore informations regarding past and present health condition will be collected from participants.
The main questions it aims to answer are:
- What is the profile of memory and learning among polish adults?
- Do gender and age moderates patterns of memory and learning functioning among polish adults?
- What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes?
- Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes?
Researchers will compare the following groups of adults:
- general population/control group
- with neurologically recognized aphasic syndromes
- seniors (over 60 y.o.)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rafał Nowicki, M.A.
- Phone Number: +48509805591
- Email: nowicki@pracowniatestow.pl
Study Locations
-
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Pomerania
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Gdansk, Pomerania, Poland, 80-239
- Recruiting
- Laboratory of Psychological and Educational Tests
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Contact:
- Rafał Nowicki, M.A.
- Phone Number: +48509805591
- Email: nowicki@pracowniatestow.pl
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Sub-Investigator:
- Rafał Nowicki, M.A.
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Sub-Investigator:
- Artur Sawicki, M.A.
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Principal Investigator:
- Urszula Sajewicz-Radtke, Ph.D.
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Principal Investigator:
- Bartosz M Radtke, Ph.D.
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Principal Investigator:
- Ariadna Łada-Maśko, Ph.D.
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Sub-Investigator:
- Beata Daniluk, Ph.D.
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Sub-Investigator:
- Piotr Markiewicz, Ph.D.
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Sub-Investigator:
- Paweł Jurek, Ph.D.
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Sub-Investigator:
- Michał Olech, Ph.D.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria for general population/control group:
- age from 18 to 60 y.o.
Inclusion criteria for neurologically recognized aphasic syndromes
- age above 18 y.o.
- neurologically recognized aphasic syndromes
Inclusion criteria for seniors:
- age above 60 y.o.
Exclusion criteria for general population/control group:
- age less then 18 y.o.
- neurologically recognized aphasic syndromes
Exclusion criteria for neurologically recognized aphasic syndromes
- age less then 18 y.o.
- no neurologically recognized aphasic syndromes
Exclusion criteria for seniors
- age less then 60 y.o.
- diseases of the nervous system, such as: stroke, craniocerebral trauma, neuroinfections, neurodegenerative diseases
- mental disorders such as depression, psychotic disorders, anxiety disorders, addictions
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
General population/control group
Polish adults (age 18 to 60 y.o).
|
Psychological assessment of memory, learning and language
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Neurologically recognized aphasic syndromes
Polish adults (age 18 to 60 y.o) with neurologically recognized aphasic syndromes.
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Psychological assessment of memory, learning and language
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Seniors (over 60 y.o)
Polish adults (over 60 y.o.)
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Psychological assessment of memory, learning and language
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Socio-demographic data
Time Frame: July 3, 2023 until March 31, 2025
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Author's survey of socio-demographic data, including: gender, month and year of birth, region of residence
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July 3, 2023 until March 31, 2025
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Memory and learning
Time Frame: July 3, 2023 until March 31, 2025
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Test of Memory and Learning (second edition).
A standardized test measuring memory functioning and learning abilities.
The test includes four basic factors (Verbal Memory, Nonverbal Memory, Complex Memory, and Delayed Recall) and five supplementary factors (Attention/Concentration, Sequential Memory, Free Recall, Associative Recall and Learning).
The raw scores obtained in each tested subscale are converted into scores scaled based on age norms, ranging from 1 to 20, where a higher score means better functioning of the examined area, and a lower result means poorer functioning.
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July 3, 2023 until March 31, 2025
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Language
Time Frame: July 3, 2023 until March 31, 2025
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Boston Diagnostic Aphasia Examination-Third Edition.
A spectrum of tools that helps to identify and distinguish among disorders of language function and neurologically recognized aphasic syndromes.
The test have five functional subsections: 1) Conversational and Expository Speech, 2) Auditory Comprehension, 3) Oral Expression, 4) Reading and 5) Writing.
The raw scores obtained in each tested subscale are converted into a percentile scale, ranging from 1 to 100, where a higher score means better functioning of the examined area, and a lower result means poorer functioning.
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July 3, 2023 until March 31, 2025
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related data
Time Frame: July 3, 2023 until March 31, 2025
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Author's survey of health related data, including: hearing, eyesight, hypertension, atherosclerosis, previous heart attack, diabetes, endocrine diseases, respiratory system diseases, musculoskeletal system diseases, nervous system diseases, kidney diseases, sleep disorders, hospitalizations, procedures under general anesthesia, cancer, medications.
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July 3, 2023 until March 31, 2025
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Education data
Time Frame: July 3, 2023 until March 31, 2025
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Author's survey of education, including: years of education, level of education, occupation, level of education of the participant's parents.
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July 3, 2023 until March 31, 2025
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General mental state
Time Frame: July 3, 2023 until March 31, 2025
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Mini-Mental State Examination.
A clinical scale used to examine disorders in a patient's cognitive functioning.
The questionnaire consists a series of questions allowing the assessment of the following functions: 1) orientation in time and place, 2) attention/concentration, 3) short-term memory (recall), 4) language skills, 5) visual-spatial abilities, 6) ability to understand and follow the instructions.
The maximum score that can be obtained on the test is 30 points.
27-30 is a correct result; 24-26 is a cognitive impairment without dementia; 19-23 mean mild dementia; 11-18 is a moderate degree dementia and 0-10 mean profound dementia.
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July 3, 2023 until March 31, 2025
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ariadna Łada-Maśko, Ph.D., Laboratory of Psychological and Educational Tests
- Study Director: Urszula Sajewicz-Radtke, Ph.D., Laboratory of Psychological and Educational Tests
- Principal Investigator: Bartosz M Radtke, Ph.D., Laboratory of Psychological and Educational Tests
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/PTPiP/1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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