Cognitive-driven ADL Impairment as a Predictor for PDD

NCT03687203 | Completed

• 1 other identifier: 284/2018BO1
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Activity of daily living function; Cognitive impairment; Parkinson's disease dementia

Outcome Measures

Primary Outcomes (1)

• Functional Activity Questionnaire

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

  8 minutes

Interventions

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.

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

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

Study Sites (1)

University hospital of Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Through venipuncture, the following samples will be taken: * venous blood for the determination of routine values (1 Serum tube) * venous blood for RNA Isolation * venous blood for DNA isolation * venous blood in 1 Serum tube 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.

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Inga Liepelt-Scarfone, PhD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 27, 2018
• Study Start: July 20, 2018
• Primary Completion: October 15, 2020
• Study Completion: January 31, 2021
• Last Updated: February 24, 2022

Record last verified: 2021-01

Locations

DE (1)