Cognitive-driven ADL Impairment as a Predictor for PDD

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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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participation in the baseline assessment
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 their right to withdraw consent at any time without prejudice to future medical care.

Exclusion criteria

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 for 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 PD, e.g. head trauma, stroke, encephalitis, etc.

Treatment and study plan

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.

Primary outcomes

Functional Activity Questionnaire

Time frame: 8 minutes

Assessment of cognitive- and motor driven activity of daily living function

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

Advisory board, Prof. Dr. Berg, Christian-Albrechts-University, Kiel, Germany
Advisory board, Prof. Dr. Thomas Gasser, University Hospital of Tuebingen, Tuebingen, Germany
Sub-Investigator, Dr. Kathrin Brockmann, University Hospital of Tuebingen, Tuebingen, Germany

Registry information

Official study title

Cognitive-driven ADL Impairment as a Predictor for Parkinson's Disease Dementia (PDD)

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Sep 27, 2018
Registry last updated: Feb 24, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed