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Not yet recruiting NCT07114354

Enhancing Utility of Neuropsychological Evaluation for Earlier and Effective Diagnosis of Dementia in Parkinson's Disease

No phase Interventional Dementia (Diagnosis) Parkinson Disease Dementia (PDD) Parkinson Disease (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PDCogniCare platform.
Who it may be relevant to
Registry conditions: Dementia (Diagnosis), Parkinson Disease Dementia (PDD), Parkinson Disease (PD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Dementia is observed in 80% of people living with advanced stage Parkinson's disease, however, there are inadequate opportunities for early and effective diagnosis of dementia in current clinical practice. This study aims to identify whether a new tool called PDCogniCare, can improve detection of dementia in people living with Parkinson's disease, and to explore what factors might influence its use in healthcare services.

Detailed description

The PDCogniCare tool integrates best practice guidelines for cognitive evaluations in people living with Parkinson's disease, along with a tailored digital platform to support guideline implementation and routinely track cognitive changes throughout the disease course. We hypothesize that PDCogniCare will significantly enhance cognitive evaluations within healthcare services. Embedded process and economics evaluations will inform implementation and sustainable business models of PDCogniCare.

Interventions

  • Other PDCogniCare platform
    Digital platform designed to support early and accurate detection of dementia in people living with Parkinson's disease

Primary outcome measures

  • Change in percentage of people with Parkinson's disease diagnosed with dementia [Time frame: 12 months from enrolment]
Secondary outcome measures (1)
  • Change in percentage of people with Parkinson's disease diagnosed with mild cognitive impairment [Time frame: 12 months from enrolment]

Eligibility criteria

Inclusion criteria

  • People living with idiopathic Parkinson's disease, one year or more post-diagnosis, attending Movement Disorder Clinics

Exclusion criteria

  • People with severe Parkinson's disease who aren't able to communicate
  • People with comorbid neurological conditions (e.g. Stroke)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Pourzinal D, King J, Sivakumaran K, Yang J, McCann E, Mitchell LK, Brooks D, Lehn A, Liddle J, Pachana NA, Tinson H, Shrubsole K, Bailey DX, Dissanayaka NN. Evaluating evidence for a neuropsychological toolkit to predict cognitive decline in PD: A systematic review. Clin Neuropsychol. 2026 Jul;40(5):1289-1316. doi: 10.1080/13854046.2025.2511966. Epub 2025 Jun 4. PMID 40464273
  • Pourzinal D, Elgey C, Bailey DX, Yang J, Lehn A, Tinson H, Liddle J, Brooks D, Naismith SL, Shrubsole K, Marsh R, Mitchell LK, Pachana NA, King J, Dissanayaka NN. Diagnosis, evaluation & management of cognitive disorders in Parkinson's disease: A systematic review. Int Psychogeriatr. 2025 May 12:100081. doi: 10.1016/j.inpsyc.2025.100081. Online ahead of print. PMID 40360335

Identifiers

NCT: NCT07114354 · HREC/2023/MNHA/100098

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗