Cognitive ImpairmentPAPSYNCT05843357
PAPSY - Memory in Psychiatry
An observational study of Cognitive Impairment, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Memory in Psychiatry project (PAPSY) aims to map the distribution and severity of cognitive impairment in patients of outpatient psychiatric offices across the geographical area of the Czech Republic. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cognitive Impairment
- How many people
- 1,000 participants
- Where
- 1 siteCzechia
- Study dates
- 8 Mar 2023to Dec 2027
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population is intended to be comprised of persons (45yrs+) living in the geographical area of the Czech Republic undergoing a treatment at an outpatient psychiatric office for a diagnosis defined in ICD-10 (excluding mental retardation). The probability sample will be created by a random selection of persons undergoing their regular outpatient psychiatric checkups.
Who may be able to join
- Dispensarization of at least six months in an outpatient psychiatric office with an ICD-10 diagnosis
- Age>=45
- Permanent residency in the geographical area of the Czech Republic
Who cannot join
- Diagnosis of mental retardation (F70-F79) according to ICD-10
- Refusal to sign the informed consent and consent with GDPR
- Uncorrected visual impairment
- Uncorrected auditory impairment
- Inability to participate in the project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PAPSY: Snadné zjištění Poruch paměti pomocí Velmi krátkých testů ALBA a POBAV u psychiatrických diagnóz v celé ČR
Memory in Psychiatry project (PAPSY) aims to map the distribution and severity of cognitive impairment in patients of outpatient psychiatric offices across the geographical area of the Czech Republic. 1000 patients in 90 psychiatric offices will undergo cognitive tests (ALBA and PICNIR) and psychometric scales (sFAQ-CZ and GDS-CZ) to asses their functional state and depressive symptoms. If applicable, caretakers will also be asked about the extent of the participant's autonomy and behavioral impairment (using oFAQ-CZ and MBI-C-CZ scales).
The trial's primary goal is to assess the distribution of cognitive impairment among diagnostic groups in psychiatric care according to the ICD-10. Additionally, the feasibility of ALBA and PICNIR methods to uncover previously undiagnosed cognitive impairments will be evaluated.
- Conditions
- Cognitive Impairment
- Keywords
- Cognitive Impairment, Outpatient Psychiatric Service, Population Distribution
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observed group | No intervention will be administered on behalf of the project. The participants will be tested using ALBA and PICNIR (non-invasive) cognitive tests, and further sFAQ-CZ and GDS-CZ questionnaires will be administered. Questionnaires FAQ-CZ and MBI-C-CZ will be distributed to participants´ caretakers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline ALBA
Amnesia Light and Brief Assessment (ALBA) test is an innovative method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-12 (a lower value denotes a more severe cognitive impairment).
Measured: Established on Day 0 as a single assessment.
Baseline PICNIR
Picture Naming and Immediate Recall test (PICNIR) is an innovative test method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-20 (a lower value denotes a more severe cognitive impairment).
Measured: Established on Day 0 as a single assessment.
Statistical analysis of ALBA results,
Statistical analysis of ALBA results compared to groups determined by ICD-10 diagnosis and demographical data.
Measured: The final statistical analysis will be performed through study completion, an average of 6 months.
Statistical analysis of PICNIR results.
Statistical analysis of PICNIR results compared to groups determined by ICD-10 diagnosis and demographical data.
Measured: The final statistical analysis will be performed through study completion, an average of 6 months.
Secondary outcomes (4)
Baseline MBI-C-CZ
Mild Behavioral Impairment - Checklist - Czech version (MBI-C-CZ) is a standardized questionnaire to assess behavioral impairment in 34 items. Each item is scaled between 0-3 (a higher value denotes a higher severity) to reach the overall score between 0-102 (a higher value denotes a higher overall severity of behavioral impairments)
Measured: Established as a baseline on Day 0.
Baseline sFAQ-CZ
Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities. Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency). This version of the scale will be used for participants´ self-evaluation.
Measured: Established as a baseline on Day 0.
Baseline GDS-CZ
The Geriatric Depression Scale - Czech version (GDS-CZ) is a standardized questionnaire administered to assess depressive symptoms, particularly in the elderly population. Fifteen items are scaled between 0-1 to reach the overall score between 0-15 (a higher value denotes a higher level of depressive symptoms).
Measured: Established as a baseline on Day 0.
Baseline oFAQ-CZ
Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities. Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency). This version of the scale will be used for caretakers´ evaluation of participants´ functioning.
Measured: Established as a baseline on Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start8 Mar 2023
- Primary completion1 Dec 2023
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadeáš Mareš, Charles University, Czech Republic
- Investigators
- Aleš Bartoš, M.D., Ph.D., Principal investigator, Charles University, Czech RepublicTadeáš Mareš, M.D., Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843357
- Sponsor's protocol ID
- PAPSY
- Acronym
- PAPSY
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is to be shared upon request by a verified researcher. The study director´s discretion is reserved.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAPSY: Snadné zjištění Poruch paměti pomocí Velmi krátkých testů ALBA a POBAV u psychiatrických diagnóz v celé ČR
- ClinicalTrials.gov ID
- NCT05843357
- Acronym / sponsor ID
- PAPSY / PAPSY
- Conditions
- Cognitive Impairment
- Keywords
- Cognitive Impairment, Outpatient Psychiatric Service, Population Distribution
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 May 2023 (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.
Memory in Psychiatry project (PAPSY) aims to map the distribution and severity of cognitive impairment in patients of outpatient psychiatric offices across the geographical area of the Czech Republic. 1000 patients in 90 psychiatric offices will undergo cognitive tests (ALBA and PICNIR) and psychometric scales (sFAQ-CZ and GDS-CZ) to asses their functional state and depressive symptoms. If applicable, caretakers will also be asked about the extent of the participant's autonomy and behavioral impairment (using oFAQ-CZ and MBI-C-CZ scales).
The trial's primary goal is to assess the distribution of cognitive impairment among diagnostic groups in psychiatric care according to the ICD-10. Additionally, the feasibility of ALBA and PICNIR methods to uncover previously undiagnosed cognitive impairments will be evaluated.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed group | – | –No intervention will be administered on behalf of the project. The participants will be tested using ALBA and PICNIR (non-invasive) cognitive tests, and further sFAQ-CZ and GDS-CZ questionnaires will be administered. Questionnaires FAQ-CZ and MBI-C-CZ will be distributed to participants´ caretakers. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is intended to be comprised of persons (45yrs+) living in the geographical area of the Czech Republic undergoing a treatment at an outpatient psychiatric office for a diagnosis defined in ICD-10 (excluding mental retardation). The probability sample will be created by a random selection of persons undergoing their regular outpatient psychiatric checkups.
Key inclusion criteria (3 listed)
- Dispensarization of at least six months in an outpatient psychiatric office with an ICD-10 diagnosis
- Age>=45
- Permanent residency in the geographical area of the Czech Republic
Key exclusion criteria (5 listed)
- Diagnosis of mental retardation (F70-F79) according to ICD-10
- Refusal to sign the informed consent and consent with GDPR
- Uncorrected visual impairment
- Uncorrected auditory impairment
- Inability to participate in the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline ALBA
Time frame: Established on Day 0 as a single assessment.
Amnesia Light and Brief Assessment (ALBA) test is an innovative method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-12 (a lower value denotes a more severe cognitive impairment).
Baseline PICNIR
Time frame: Established on Day 0 as a single assessment.
Picture Naming and Immediate Recall test (PICNIR) is an innovative test method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-20 (a lower value denotes a more severe cognitive impairment).
Statistical analysis of ALBA results,
Time frame: The final statistical analysis will be performed through study completion, an average of 6 months.
Statistical analysis of ALBA results compared to groups determined by ICD-10 diagnosis and demographical data.
Statistical analysis of PICNIR results.
Time frame: The final statistical analysis will be performed through study completion, an average of 6 months.
Statistical analysis of PICNIR results compared to groups determined by ICD-10 diagnosis and demographical data.
4 secondary outcomes
Baseline MBI-C-CZ
Time frame: Established as a baseline on Day 0.
Baseline sFAQ-CZ
Time frame: Established as a baseline on Day 0.
Baseline GDS-CZ
Time frame: Established as a baseline on Day 0.
Baseline oFAQ-CZ
Time frame: Established as a baseline on Day 0.
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 22 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD is to be shared upon request by a verified researcher. The study director´s discretion is reserved.
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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. This study is not recruiting at the moment.
Aleš Bartoš, M.D., Ph.D. principal investigator
Charles University, Czech Republic
Tadeáš Mareš, M.D. principal investigator
Charles University, Czech Republic
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 Cognitive Impairment, run by Charles University, Czech Republic at 1 site in Czechia.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 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 Czechia. 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?
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?
Baseline ALBA (time frame: Established on Day 0 as a single assessment.). The study lists 4 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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.