Clinical Trials Directory

Trials / Completed

CompletedNCT03687203

Cognitive-driven ADL Impairment as a Predictor for PDD

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

Status
Completed
Phase
Study type
Observational
Enrollment
182 (actual)
Sponsor
University Hospital Tuebingen · Academic / Other
Sex
All
Age
50 Years – 90 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTFunctional Activities QuestionnaireThe 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.

Timeline

Start date
2018-07-20
Primary completion
2020-10-15
Completion
2021-01-31
First posted
2018-09-27
Last updated
2022-02-24

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03687203. Inclusion in this directory is not an endorsement.