AphasiaNCT06365658
Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective
An observational study of Aphasia and Development, Human, run by Bartosz M. Radtke at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphasia, Development, Human, Neuropathology
- What is being tested?
- Psychological assessment
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jul 2023to Dec 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Polish adults.
Who may be able to join
- age from 18 to 60 y.o.
- Inclusion criteria for neurologically recognized aphasic syndromes
- age above 18 y.o.
- neurologically recognized aphasic syndromes
- age above 60 y.o.
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Laboratory of Psychological and Educational Tests
Gdansk, Pomeranian Voivodeship, 80-239
Rafał Nowicki, M.A., +48509805591, nowicki@pracowniatestow.pl
Urszula Sajewicz-Radtke, Ph.D.
About this study
Official title: 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.
Read more
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.)
- Conditions
- Aphasia, Development, Human, Neuropathology
- Being tested
- Psychological assessment
- Keywords
- aphasia, memory, learning, language, adults, seniors
- Medical subject headings
- Aphasia, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological assessmentDiagnostic test
Psychological assessment of memory, learning and language
| Study group | Role | What they receive |
|---|---|---|
| General population/control group | Polish adults (age 18 to 60 y.o). Receives: Diagnostic Test: Psychological assessment | |
| Neurologically recognized aphasic syndromes | Polish adults (age 18 to 60 y.o) with neurologically recognized aphasic syndromes. Receives: Diagnostic Test: Psychological assessment | |
| Seniors (over 60 y.o) | Polish adults (over 60 y.o.) Receives: Diagnostic Test: Psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory and learning
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.
Measured: July 3, 2023 until June 30, 2026
Language
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.
Measured: July 3, 2023 until June 30, 2026
Socio-demographic data
Author's survey of socio-demographic data, including: gender, month and year of birth, region of residence
Measured: July 3, 2023 until June 30, 2026
Secondary outcomes (3)
General mental state
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.
Measured: July 3, 2023 until June 30, 2026
Health related data
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.
Measured: July 3, 2023 until June 30, 2026
Education data
Author's survey of education, including: years of education, level of education, occupation, level of education of the participant's parents.
Measured: July 3, 2023 until June 30, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start3 Jul 2023
- Primary completion30 Jun 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartosz M. Radtke
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Bartosz M. Radtke, Laboratory of Psychological and Educational Tests
- Investigators
- Urszula Sajewicz-Radtke, Ph.D., Study director, Laboratory of Psychological and Educational TestsBartosz M Radtke, Ph.D., Principal investigator, Laboratory of Psychological and Educational TestsAriadna Łada-Maśko, Ph.D., Principal investigator, Laboratory of Psychological and Educational Tests
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365658
- Sponsor's protocol ID
- 2024/PTPiP/1
- Status last verified
- Aug 2026
- First submitted
- 10 Apr 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Functioning Profiles in Adults With Neurologically Recognized Aphasic Syndromes and General Population From a Biopsychosocial Perspective
- ClinicalTrials.gov ID
- NCT06365658
- Acronym / sponsor ID
- 2024/PTPiP/1
- Conditions
- Aphasia, Development, Human, Neuropathology
- Keywords
- aphasia, memory, learning, language, adults, seniors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Bartosz M. RadtkeOther government
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Apr 2024 (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 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General population/control group | – | Diagnostic Test: Psychological assessmentPolish adults (age 18 to 60 y.o). |
| Neurologically recognized aphasic syndromes | – | Diagnostic Test: Psychological assessmentPolish adults (age 18 to 60 y.o) with neurologically recognized aphasic syndromes. |
| Seniors (over 60 y.o) | – | Diagnostic Test: Psychological assessmentPolish adults (over 60 y.o.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Polish adults.
Key inclusion criteria (5 listed)
- age from 18 to 60 y.o.
- Inclusion criteria for neurologically recognized aphasic syndromes
- age above 18 y.o.
- neurologically recognized aphasic syndromes
- age above 60 y.o.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Psychological assessmentPsychological assessment of memory, learning and language | Diagnostic test | General population/control group, Neurologically recognized aphasic syndromes, Seniors (over 60 y.o) |
Primary outcome
Memory and learning
Time frame: July 3, 2023 until June 30, 2026
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.
Language
Time frame: July 3, 2023 until June 30, 2026
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.
Socio-demographic data
Time frame: July 3, 2023 until June 30, 2026
Author's survey of socio-demographic data, including: gender, month and year of birth, region of residence
3 secondary outcomes
General mental state
Time frame: July 3, 2023 until June 30, 2026
Health related data
Time frame: July 3, 2023 until June 30, 2026
Education data
Time frame: July 3, 2023 until June 30, 2026
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 26 Aug 2026.
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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.
Urszula Sajewicz-Radtke, Ph.D. study director
Laboratory of Psychological and Educational Tests
Bartosz M Radtke, Ph.D. principal investigator
Laboratory of Psychological and Educational Tests
Ariadna Łada-Maśko, Ph.D. principal investigator
Laboratory of Psychological and Educational Tests
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 Aphasia and Development, Human, run by Bartosz M. Radtke at 1 site in Poland.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. 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 Poland. 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 Rafał Nowicki, M.A. (+48509805591, nowicki@pracowniatestow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory and learning (time frame: July 3, 2023 until June 30, 2026). The study lists 3 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 26 Aug 2026.