Progression in Cognitive ADLs in Parkinson's Disease

NCT05806866 | Unknown

• 1 other identifier: 702/2022BO1
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Cognition; Actitvities of daily living function; Parkinson's disease dementia

Outcome Measures

Primary Outcomes (1)

• 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).

  6-8 years

Secondary Outcomes (3)

• Pfeffer Activities of daily living scale

  6-8 years

• Follow-up score in global cognition

  6-8 years

• Follow-up cognitive domain performance

  6-8 years

Interventions

Cognition scores, cognitive instrumental activities of daily living scores BEHAVIORAL

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

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Technische Universität Dresden: collaborator
• Luxembourg Institute of Health: collaborator
• IB Hochschule für Gesundheit und Soziales: collaborator

Study Sites (1)

University hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 21661055 BACKGROUND

• Dubois 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.

  PMID: 18098298 BACKGROUND

• Becker 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.

  PMID: 34109514 BACKGROUND

• 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.

  PMID: 36240089 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and cerebrospinal fluid (CSF) samples will be collected in the morning, on an empty stomach. If patients do not agree for a lumbar puncture, fasting for blood sampling is not necessary for biomarker analysis. For patients with no CSF withdrawal about 40 ml venous blood will be collected for data analysis and storage of blood in the neurobank of the Hertie Institute for Clinical Brain Research (ethic proposal: 199/2011BO1). This amount does not represent any health hazard. Of those 10 ml of venous blood (1 Serum tube) will be used for study related analysis of neurofilament light chain. If the patient agrees for withdrawal of CSF additional 12,5 ml venous blood (2 serum tube, 1 glucose) will be taken for safety analysis.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Inga Liepelt-Scarfone, PhD

  Eberhard Karls Universität Tübingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inga Liepelt-Scarfone, PhD

CONTACT

004970712980424; inga.liepelt@uni-tuebingen.de

Susanne Solbrig, M.Sc.

CONTACT

004970712982734; Susanne.Solbrig@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 10, 2023
• Study Start: March 22, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: During conduct and analysis
• Access Criteria: Access will be granted upon reasonable request.

Locations

DE (1)