Parkinson DiseasePRICOG-PDNCT05806866
Progression in Cognitive ADLs in Parkinson's Disease
An observational study of Parkinson Disease, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Mild cognitive impairment (PD-MCI) is one of the greatest risk factors for future Parkinson's disease dementia (PDD). A recent meta-analysis found that, on average, 31% of patients with PD-MCI converted to PDD within seven years; however, 24% of patients with PD-MCI reverted back to normal cognitive function. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cognition scores, cognitive instrumental activities of daily living scores
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 22 Mar 2023to 31 Dec 2024
- 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 50 to 95 years
- All sexes
- Adult, Older adult
Study population: Participants of the already recruited cross-sectional cohort will be asked to participate in the follow-up assessment. People with Parkinson's disease who did not agree to participate in a longitudinal study or who have asked not to be contacted after the first cross-sectional assessment will not be contacted again. A drop-out rate of 20% is expected for follow-up retention. Therefore, investigation of 145 people with Parkinson's disease will be primarily conducted between January 2023 and June 2024. During the executive project phase, around 7 to 9 patients will be assessed per month. People with Parkinson's disease will be contacted either via phone or in written form. Reasons for drop-outs will be registered for data analysis.
Who may be able to join
- Participant in the " Amyloid-Beta in cerebrospinal fluid as a risk factor for cognitive dysfunction in Parkinson's Disease" (ABC-PD) study
- Diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria.
- Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
- Provide written informed consent to participate in the study and understand the right to withdraw consent at any time without prejudice to future medical care.
- If people with Parkinson's disease are not able to give consent for study participation (confirmed by an independent physician), study consent of a legal guardian is required.
Who cannot join
- Any disability that may prevent the subject from completing the informed consent form or other study requirements.
- Other neurodegenerative disease which renders the subject unable to communicate well with the investigator or to understand and comply with the requirements of the study.
- Participation in any clinical investigation of a new investigational compound or therapy within 4 weeks prior to baseline visit, and any other limitation of participation based on local regulations.
- Alcohol, medication, or drug dependency or abuse (except for nicotine).
- History of brain disease other than Parkinson's disease, e.g., head trauma, stroke, encephalitis.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Progression in Cognition and Associated Activities of Daily Living (ADL) Impairment in Parkinson's Disease
Mild cognitive impairment (PD-MCI) is one of the greatest risk factors for future Parkinson's disease dementia (PDD). A recent meta-analysis found that, on average, 31% of patients with PD-MCI converted to PDD within seven years; however, 24% of patients with PD-MCI reverted back to normal cognitive function. Consequently, the false positive rate for predicting PDD among patients with PD-MCI is high, and better predictive markers to define patients at high risk for PDD development are urgently needed. Therefore, a combination of different markers, including clinical, genetic, and other biomarker data, are proposed to increase ability to predict cognitive worsening and dementia. Based on data of the first follow-up of this cohort results indicated that presence of both mild cognitive instrumental activities of daily living (IADL) impairment and PD-MCI dramatically increases the risk for PDD (PubMed ID: 36240089). This study evaluates markers predicting cognitive and IADL long-term outcome in our sample. Additionally, focus of the study is the investigation whether ratings of patients or informants best predicted decline of cognitive impairment and/or everyday function. Clinical data along with other clinical marker and biomarker status will be investigated.
Read the detailed description
Patients assessments: Most scales (except for Kölner Apraxie Test) were also included in the first follow-up of the sample. Total duration of scales and questionnaires is 4 hours (total time of mandatory in house assessments: 115 min).
Demographic and lifestyle data: Age, gender, education, occupation, family history of neurodegenerative diseases, smoking/drinking behavior, height \& weight will be registered.
Activities of daily living assessment: The total and subscores of the Pfeffer Functional Activities Questionnaire (score range 0 to 30 higher values indicating more impairment) will be assessed. Additionally patients assessment includes the Parkinson's disease Activity of daily living scale (five level scale, higher values indicating more impairment).
Neuropsychological Assessment: History and self-awareness of cognitive deficits will be asked. Overall mean z-score (range -3.00 poor performance to +3.00 excellent performance) and cognitive domain score (mean z-score of tests assigned to one domain) will be quantitatively assessed using the Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus) battery, three subtests of the Wechsler Intelligence Test for Adults (WIE), and one subtest of the Leistungsprüfsystem für 50- bis 90-Jährige (LPS 50+). The MMSE included in the CERAD-Plus, as well as the Montreal Cognitive Assessment (MoCA) will serve as global cognitive screening scales.
- Executive functions: Lexical and Phonemic Fluency (CERAD-Plus), Trail Making Test Part B (CERAD-Plus)
- Attention/working memory: Digit-Symbol Test (WIE), Letter-Number Sequencing (WIE)
- Language: Boston Naming Test (CERAD-Plus), Similarities (WIE)
- Memory: Word List Learning, Recall, and Discriminability (CERAD-Plus), Praxis Recall (CERAD-Plus)
- Visuospatial abilities: Praxis (CERAD-Plus), Fragmented Words (LPS-50+)
The Dementia Apraxia Test developed to assess limb and buccofacial apraxia in neurocognitive disorder patients with Alzheimer's disease and frontotemporal dementia will be additionally applied. For validation purpose, the Kölner Apraxie Screening will be included as well.
Clinical motor assessment: The Movement Disorder Society Unified Parkinson's disease rating scale (score 0 to 132) including the Hoehn and Yahr stage (score 0-5) will be applied. The Freezing of Gait Questionnaire (FOG) will be applied. Higher scale values indicated more severe impairment.
Additional non-motor assesssment: A comprehensive non-motor assessment will be applied including the Beck Depression Inventory II (BDI-II, score 0-63), the Beck Anxiety Scale (score 0-63), the Non-motor symptom Questionnaire (NMSQ, 0 to 30) and the Parkinson's disease Non-Motor Symptom Scale, subscales 1-5 (PD-NMS-S). In those scales higher values indicated more severe impairment.
Optional assessments:
- Blood withdrawal - 15 min
- Lumbar puncture - 30 min
- Ambulatory accelerometry device - 7 days
Caregiver assessments: To validate the patients' self-impression, caregiver questionnaires and interview scales will be applied, needing caregivers to be available for at least 38 minutes. Caregiver assessments will only be performed if the respective patient has agreed to the interview. The Bayer Activities of Daily Living Scale (1 point to 10 points with higher values indicating more impairment) answered by the caregiver and the Informant Questionnaire on Cognitive Decline in the Elderly (IQ-CODE, 26 points to 130 points, higher scores indicating more impaired performance) will be analysed.
- Conditions
- Parkinson Disease
- Being tested
- Cognition scores, cognitive instrumental activities of daily living scores
- Keywords
- Parkinson's disease, Cognition, Actitvities of daily living function, Parkinson's disease dementia
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognition scores, cognitive instrumental activities of daily living scoresBehavioural
A detailed neuropsychological test battery will be applied. The Functional Activitites Questionnaire (FAQ) subscores will be used to define cognitive and motor instrumental activities of daily living function
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Parkinson's disease dementia (PDD) / Level II diagnosis of mild cognitive impairment in Parkinson's disease (PD-MCI)
Patients will be classified as PD-MCI according to Level-II Movement Disorder Society recommendations if cognitive impairment was present but did not significantly interfere with everyday function [PubMed ID: 21661055] according to a personalized interview. PDD was defined according to Movement Disorder Society Task Force criteria [PubMed ID: 18098298] if cognitive impairment was present and severe enough to impair activities of daily living function unrelated to motor or autonomic symptoms. Cognitive impairment will be defined according to Level-I (impairment of global cognition) for patients with minimal assessments, or Level-II (performance below 1.5 standard deviation of the population mean reported in the test manuals on at least two tests) for patients assessed using a full cognitive battery. Assessment include a detailed neuropsychological test battery (see below).
Measured: 6-8 years
Secondary outcomes (3)
Pfeffer Activities of daily living scale
Baseline/follow-up comparison of instrumental activities of daily living (IADL) function (patients' self-impression vs. informant-rating) primarily based on the motor, cognitive and total score of the Pfeffer Activities of daily living scale.
Measured: 6-8 years
Follow-up score in global cognition
Overall mean z-score (range -3.00 poor performance to +3.00 excellent performance) of all tests assessed will be used to define global cognitive performance. For people with Parkinson's disease and incomplete neuropsychological test scores the MoCA will be used to define global cognitive performance.
Measured: 6-8 years
Follow-up cognitive domain performance
Mean z-score of tests assigned to one cognitive domain will be used to define domain specific change in cognition.
Measured: 6-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start22 Mar 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden, Luxembourg Institute of Health, IB Hochschule für Gesundheit und Soziales
- Responsible party
- Sponsor
- Investigators
- Inga Liepelt-Scarfone, PhD, Principal investigator, Eberhard Karls Universität Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806866
- Sponsor's protocol ID
- 702/2022BO1
- Acronym
- PRICOG-PD
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol
Publications
Litvan I, Aarsland D, Adler CH, Goldman JG, Kulisevsky J, Mollenhauer B, Rodriguez-Oroz MC, Troster AI, Weintraub D. MDS Task Force on mild cognitive impairment in Parkinson's disease: critical review of PD-MCI. Mov Disord. 2011 Aug 15;26(10):1814-24. doi: 10.1002/mds.23823. Epub 2011 Jun 9.
PubMed 21661055Dubois B, Burn D, Goetz C, Aarsland D, Brown RG, Broe GA, Dickson D, Duyckaerts C, Cummings J, Gauthier S, Korczyn A, Lees A, Levy R, Litvan I, Mizuno Y, McKeith IG, Olanow CW, Poewe W, Sampaio C, Tolosa E, Emre M. Diagnostic procedures for Parkinson's disease dementia: recommendations from the movement disorder society task force. Mov Disord. 2007 Dec;22(16):2314-24. doi: 10.1002/mds.21844.
PubMed 18098298Becker S, Pauly C, Lawton M, Hipp G, Bowring F, Sulzer P, Hu M, Kruger R, Gasser T, Liepelt-Scarfone I. Quantifying activities of daily living impairment in Parkinson's disease using the Functional Activities Questionnaire. Neurol Sci. 2022 Feb;43(2):1047-1054. doi: 10.1007/s10072-021-05365-1. Epub 2021 Jun 10.
PubMed 34109514Becker S, Bode M, Brockmann K, Gasser T, Michaelis K, Solbrig S, Nuerk HC, Schulte C, Maetzler W, Zimmermann M, Berg D, Liepelt-Scarfone I. Cognitive-Driven Activities of Daily Living Impairment as a Predictor for Dementia in Parkinson Disease: A Longitudinal Cohort Study. Neurology. 2022 Dec 5;99(23):e2548-e2560. doi: 10.1212/WNL.0000000000201201.
PubMed 36240089
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression in Cognition and Associated Activities of Daily Living (ADL) Impairment in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05806866
- Acronym / sponsor ID
- PRICOG-PD / 702/2022BO1
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Cognition, Actitvities of daily living function, Parkinson's disease dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Technische Universität Dresden, Luxembourg Institute of Health, IB Hochschule für Gesundheit und Soziales
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Apr 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.
Mild cognitive impairment (PD-MCI) is one of the greatest risk factors for future Parkinson's disease dementia (PDD). A recent meta-analysis found that, on average, 31% of patients with PD-MCI converted to PDD within seven years; however, 24% of patients with PD-MCI reverted back to normal cognitive function. Consequently, the false positive rate for predicting PDD among patients with PD-MCI is high, and better predictive markers to define patients at high risk for PDD development are urgently needed. Therefore, a combination of different markers, including clinical, genetic, and other biomarker data, are proposed to increase ability to predict cognitive worsening and dementia. Based on data of the first follow-up of this cohort results indicated that presence of both mild cognitive instrumental activities of daily living (IADL) impairment and PD-MCI dramatically increases the risk for PDD (PubMed ID: 36240089). This study evaluates markers predicting cognitive and IADL long-term outcome in our sample. Additionally, focus of the study is the investigation whether ratings of patients or informants best predicted decline of cognitive impairment and/or everyday function. Clinical data along with other clinical marker and biomarker status will be investigated.
Detailed description
Patients assessments: Most scales (except for Kölner Apraxie Test) were also included in the first follow-up of the sample. Total duration of scales and questionnaires is 4 hours (total time of mandatory in house assessments: 115 min).
Demographic and lifestyle data: Age, gender, education, occupation, family history of neurodegenerative diseases, smoking/drinking behavior, height \& weight will be registered.
Activities of daily living assessment: The total and subscores of the Pfeffer Functional Activities Questionnaire (score range 0 to 30 higher values indicating more impairment) will be assessed. Additionally patients assessment includes the Parkinson's disease Activity of daily living scale (five level scale, higher values indicating more impairment).
Neuropsychological Assessment: History and self-awareness of cognitive deficits will be asked. Overall mean z-score (range -3.00 poor performance to +3.00 excellent performance) and cognitive domain score (mean z-score of tests assigned to one domain) will be quantitatively assessed using the Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus) battery, three subtests of the Wechsler Intelligence Test for Adults (WIE), and one subtest of the Leistungsprüfsystem für 50- bis 90-Jährige (LPS 50+). The MMSE included in the CERAD-Plus, as well as the Montreal Cognitive Assessment (MoCA) will serve as global cognitive screening scales.
- Executive functions: Lexical and Phonemic Fluency (CERAD-Plus), Trail Making Test Part B (CERAD-Plus)
- Attention/working memory: Digit-Symbol Test (WIE), Letter-Number Sequencing (WIE)
- Language: Boston Naming Test (CERAD-Plus), Similarities (WIE)
- Memory: Word List Learning, Recall, and Discriminability (CERAD-Plus), Praxis Recall (CERAD-Plus)
- Visuospatial abilities: Praxis (CERAD-Plus), Fragmented Words (LPS-50+)
The Dementia Apraxia Test developed to assess limb and buccofacial apraxia in neurocognitive disorder patients with Alzheimer's disease and frontotemporal dementia will be additionally applied. For validation purpose, the Kölner Apraxie Screening will be included as well.
Clinical motor assessment: The Movement Disorder Society Unified Parkinson's disease rating scale (score 0 to 132) including the Hoehn and Yahr stage (score 0-5) will be applied. The Freezing of Gait Questionnaire (FOG) will be applied. Higher scale values indicated more severe impairment.
Additional non-motor assesssment: A comprehensive non-motor assessment will be applied including the Beck Depression Inventory II (BDI-II, score 0-63), the Beck Anxiety Scale (score 0-63), the Non-motor symptom Questionnaire (NMSQ, 0 to 30) and the Parkinson's disease Non-Motor Symptom Scale, subscales 1-5 (PD-NMS-S). In those scales higher values indicated more severe impairment.
Optional assessments:
- Blood withdrawal - 15 min
- Lumbar puncture - 30 min
- Ambulatory accelerometry device - 7 days
Caregiver assessments: To validate the patients' self-impression, caregiver questionnaires and interview scales will be applied, needing caregivers to be available for at least 38 minutes. Caregiver assessments will only be performed if the respective patient has agreed to the interview. The Bayer Activities of Daily Living Scale (1 point to 10 points with higher values indicating more impairment) answered by the caregiver and the Informant Questionnaire on Cognitive Decline in the Elderly (IQ-CODE, 26 points to 130 points, higher scores indicating more impaired performance) will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants of the already recruited cross-sectional cohort will be asked to participate in the follow-up assessment. People with Parkinson's disease who did not agree to participate in a longitudinal study or who have asked not to be contacted after the first cross-sectional assessment will not be contacted again. A drop-out rate of 20% is expected for follow-up retention. Therefore, investigation of 145 people with Parkinson's disease will be primarily conducted between January 2023 and June 2024. During the executive project phase, around 7 to 9 patients will be assessed per month. People with Parkinson's disease will be contacted either via phone or in written form. Reasons for drop-outs will be registered for data analysis.
Key inclusion criteria (5 listed)
- Participant in the " Amyloid-Beta in cerebrospinal fluid as a risk factor for cognitive dysfunction in Parkinson's Disease" (ABC-PD) study
- Diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria.
- Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
- Provide written informed consent to participate in the study and understand the right to withdraw consent at any time without prejudice to future medical care.
- If people with Parkinson's disease are not able to give consent for study participation (confirmed by an independent physician), study consent of a legal guardian is required.
Key exclusion criteria (5 listed)
- Any disability that may prevent the subject from completing the informed consent form or other study requirements.
- Other neurodegenerative disease which renders the subject unable to communicate well with the investigator or to understand and comply with the requirements of the study.
- Participation in any clinical investigation of a new investigational compound or therapy within 4 weeks prior to baseline visit, and any other limitation of participation based on local regulations.
- Alcohol, medication, or drug dependency or abuse (except for nicotine).
- History of brain disease other than Parkinson's disease, e.g., head trauma, stroke, encephalitis.
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 |
|---|---|---|
| Cognition scores, cognitive instrumental activities of daily living scoresA detailed neuropsychological test battery will be applied. The Functional Activitites Questionnaire (FAQ) subscores will be used to define cognitive and motor instrumental activities of daily living function | Behavioural | – |
Primary outcome
Diagnosis of Parkinson's disease dementia (PDD) / Level II diagnosis of mild cognitive impairment in Parkinson's disease (PD-MCI)
Time frame: 6-8 years
Patients will be classified as PD-MCI according to Level-II Movement Disorder Society recommendations if cognitive impairment was present but did not significantly interfere with everyday function [PubMed ID: 21661055] according to a personalized interview. PDD was defined according to Movement Disorder Society Task Force criteria [PubMed ID: 18098298] if cognitive impairment was present and severe enough to impair activities of daily living function unrelated to motor or autonomic symptoms. Cognitive impairment will be defined according to Level-I (impairment of global cognition) for patients with minimal assessments, or Level-II (performance below 1.5 standard deviation of the population mean reported in the test manuals on at least two tests) for patients assessed using a full cognitive battery. Assessment include a detailed neuropsychological test battery (see below).
3 secondary outcomes
Pfeffer Activities of daily living scale
Time frame: 6-8 years
Follow-up score in global cognition
Time frame: 6-8 years
Follow-up cognitive domain performance
Time frame: 6-8 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Background: PubMed 21661055Litvan I, Aarsland D, Adler CH, Goldman JG, Kulisevsky J, Mollenhauer B, Rodriguez-Oroz MC, Troster AI, Weintraub D. MDS Task Force on mild cognitive impairment in Parkinson's disease: critical review of PD-MCI. Mov Disord. 2011 Aug 15;26(10):1814-24. doi: 10.1002/mds.23823. Epub 2011 Jun 9.
- Background: PubMed 18098298Dubois B, Burn D, Goetz C, Aarsland D, Brown RG, Broe GA, Dickson D, Duyckaerts C, Cummings J, Gauthier S, Korczyn A, Lees A, Levy R, Litvan I, Mizuno Y, McKeith IG, Olanow CW, Poewe W, Sampaio C, Tolosa E, Emre M. Diagnostic procedures for Parkinson's disease dementia: recommendations from the movement disorder society task force. Mov Disord. 2007 Dec;22(16):2314-24. doi: 10.1002/mds.21844.
- Background: PubMed 34109514Becker S, Pauly C, Lawton M, Hipp G, Bowring F, Sulzer P, Hu M, Kruger R, Gasser T, Liepelt-Scarfone I. Quantifying activities of daily living impairment in Parkinson's disease using the Functional Activities Questionnaire. Neurol Sci. 2022 Feb;43(2):1047-1054. doi: 10.1007/s10072-021-05365-1. Epub 2021 Jun 10.
- Background: PubMed 36240089Becker S, Bode M, Brockmann K, Gasser T, Michaelis K, Solbrig S, Nuerk HC, Schulte C, Maetzler W, Zimmermann M, Berg D, Liepelt-Scarfone I. Cognitive-Driven Activities of Daily Living Impairment as a Predictor for Dementia in Parkinson Disease: A Longitudinal Cohort Study. Neurology. 2022 Dec 5;99(23):e2548-e2560. doi: 10.1212/WNL.0000000000201201.
- Individual participant dataSharing planned: Yes. Study protocol
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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.
Inga Liepelt-Scarfone, PhD principal investigator
Eberhard Karls Universität Tübingen
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 Parkinson Disease, run by University Hospital Tuebingen at 1 site in Germany.
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 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: status not confirmed, as of the sponsor's last update on 10 Apr 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inga Liepelt-Scarfone, PhD (004970712980424, inga.liepelt@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Parkinson's disease dementia (PDD) / Level II diagnosis of mild cognitive impairment in Parkinson's disease (PD-MCI) (time frame: 6-8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05806866, which also lists 4 linked publications.
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 10 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.