Skip to content

Cognitive-driven ADL Impairment as a Predictor for PDD

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03687203
Enrollment
182
Registered
2018-09-27
Start date
2018-07-20
Completion date
2021-01-31
Last updated
2022-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTFunctional 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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional Activity Questionnaire8 minutesAssessment of cognitive- and motor driven activity of daily living function

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026