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NCT Number: NCT06365658

Cognitive Functioning in Adults With Somatic Diseases 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:

1. What is the profile of memory and learning among polish adults? 2. Do gender and age moderates patterns of memory and learning functioning among polish adults? 3. What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes? 4. Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes?

Researchers will compare the following groups of adults:

1. general population/control group 2. with neurologically recognized aphasic syndromes 3. seniors (over 60 y.o.)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratory of Psychological and Educational Tests

Gdansk, Pomeranian Voivodeship, 80-239, Poland

Location status: Recruiting

Location contact

Ariadna Łada-Maśko, Ph.D.

PRINCIPAL_INVESTIGATOR

Artur Sawicki, M.A.

SUB_INVESTIGATOR

Bartosz M Radtke, Ph.D.

PRINCIPAL_INVESTIGATOR

Beata Daniluk, Ph.D.

SUB_INVESTIGATOR

Michał Olech, Ph.D.

SUB_INVESTIGATOR

Paweł Jurek, Ph.D.

SUB_INVESTIGATOR

Piotr Markiewicz, Ph.D.

SUB_INVESTIGATOR

Rafał Nowicki, M.A.

CONTACT

[email protected]

+48509805591

Rafał Nowicki, M.A.

SUB_INVESTIGATOR

Urszula Sajewicz-Radtke, Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological Assessment

Diagnostic Test

Psychological assessment of memory, learning and language

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. General mental state

    Time frame: July 3, 2023 until June 30, 2026

    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.

  2. Health related data

    Time frame: July 3, 2023 until June 30, 2026

    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.

  3. Education data

    Time frame: July 3, 2023 until June 30, 2026

    Author's survey of education, including: years of education, level of education, occupation, level of education of the participant's parents.

Study contacts

Contact information is provided by the study sponsor or research team.

Rafał Nowicki, M.A.

CONTACT

[email protected]

+48509805591

Sponsors and collaborators

Lead sponsor

Bartosz M. Radtke

Other Gov

Registry information

Official study title

Cognitive Functioning Profiles in Adults With Neurologically Recognized Aphasic Syndromes and General Population From a Biopsychosocial Perspective

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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