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| Name | Class |
|---|---|
| Sub-Investigator, Dr. Kathrin Brockmann, University Hospital of Tuebingen, Tuebingen, Germany | UNKNOWN |
| Advisory board, Prof. Dr. Thomas Gasser, University Hospital of Tuebingen, Tuebingen, Germany | UNKNOWN |
| Advisory board, Prof. Dr. Berg, Christian-Albrechts-University, Kiel, Germany |
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Mild cognitive impairment in Parkinson's disease (PD-MCI) is the highest risk factor for Parkinson's disease dementia (PDD). The core feature for differentiating PDD from PD-MCI is the loss of the ability to perform activities of daily living (ADL). As Parkinson's Disease (PD) is primarily a movement disorder, the distinction between motor and cognitive contributions to ADL in PD is an obvious challenge, which the investigators aimed to explore in this study. The goal of the study is to evaluate whether PD-MCI patients with more pronounced, cognitive-driven ADL impairment are at higher risk for cognitive worsening and PDD. A longitudinal follow-up assessment of 262 non-demented PD patients will be conducted over the next two years, with a comprehensive clinical assessment as well as biomarker sampling (cerebrospinal fluid and blood markers). Primary longitudinal outcome will be conversion to PDD and PD-MCI. Conversion rates of patients with and without additional mild cognitive-driven ADL impairment at baseline will be compared. Novel scores of the Pfeffer Functional Activities Questionnaire (FAQ) are used to assess instrumental ADL, differentiating between cognitive- and motor-driven ADL impairment in PD-MCI.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Activities Questionnaire | Diagnostic Test | The FAQ is an economic and easy to apply activity of daily living scale. We aim to validate the prognostic value of novel FAQ scores, which differentiate cognitive- from motor-driven activity of daily living function. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Activity Questionnaire | Assessment of cognitive- and motor driven activity of daily living function | 8 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Participants of the already recruited ABC-PD (Amyloid-Beta in cerebrospinal fluid as a risk factor for cognitive dysfunction in Parkinson's Disease) cross-sectional cohort (Ethic Protocol of the Medical Faculty Tuebingen 686/2013B01) will be asked to participate in the follow-up assessment. A drop-out rate of 20% is expected for follow-up retention. Therefore, investigation of 209 patients will be conducted between August 2018 and April 2020.
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| Name | Affiliation | Role |
|---|---|---|
| Inga Liepelt-Scarfone, PhD | University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Tuebingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36240089 | Derived | Becker 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2018 | Feb 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| UNKNOWN |
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Through venipuncture, the following samples will be taken:
A lumbar puncture at level L3/L4 or L4/L5 of the spine will be performed by a qualified clinician in subsample of the cohort. Neurodegenerative markers such as Abeta1-42 and Abeta1-40 will be analysed.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |