Cognitive-driven ADL Impairment as a Predictor for PDD

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687203
• Other study ID #: 284/2018BO1
• Status: Completed
• Start date: July 20, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: January 2021
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: January 31, 2021
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Diagnostic Test:
• Functional Activities Questionnaire
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.

Locations

Country	Name	City	State
Germany	University hospital of Tuebingen	Tuebingen	Baden-Württemberg

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Tuebingen	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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Activity Questionnaire	Assessment of cognitive- and motor driven activity of daily living function	8 minutes