Dementia (Diagnosis)PDCogniCareNCT07114354
Enhancing Utility of Neuropsychological Evaluation for Earlier and Effective Diagnosis of Dementia in Parkinson's Disease
A study testing PDCogniCare platform in people with Dementia (Diagnosis) and Parkinson Disease Dementia (PDD), run by The University of Queensland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia (Diagnosis), Parkinson Disease Dementia (PDD), Parkinson Disease (PD)
- What is being tested?
- PDCogniCare platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People living with idiopathic Parkinson's disease, one year or more post-diagnosis, attending Movement Disorder Clinics
Who cannot join
- People with severe Parkinson's disease who aren't able to communicate
- People with comorbid neurological conditions (e.g. Stroke)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tiffany Au contact
About this study
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.
Read the 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.
- Being tested
- PDCogniCare platform
- Keywords
- Parkinson's disease, Dementia, Cognitive evaluation, Implementation
- Medical subject headings
- Dementia, Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDCogniCare platformOther
Digital platform designed to support early and accurate detection of dementia in people living with Parkinson's disease
| Study group | Role | What they receive |
|---|---|---|
| PDCogniCare | Other | All eligible people living with Parkinson's disease who consent to participate will be registered into the PDCogniCare platform. Receives: Other: PDCogniCare platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of people with Parkinson's disease diagnosed with dementia
Measured: 12 months from enrolment
Secondary outcomes (1)
Change in percentage of people with Parkinson's disease diagnosed with mild cognitive impairment
Measured: 12 months from enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start18 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dementia (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Future Fund, Metro South Health, Metro North Health, Queensland University of Technology, University of Sydney, OPN365, Australian Dementia Network, Dementia Australia, Lions Club of Brisbane Inner North, Parkinson's Queensland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114354
- Sponsor's protocol ID
- HREC/2023/MNHA/100098
- Acronym
- PDCogniCare
- Status last verified
- Jul 2025
- First submitted
- 3 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40464273Pourzinal 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.
PubMed 40360335
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Utility of Neuropsychological Evaluation for Earlier and Effective Diagnosis of Dementia in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07114354
- Acronym / sponsor ID
- PDCogniCare / HREC/2023/MNHA/100098
- Keywords
- Parkinson's disease, Dementia, Cognitive evaluation, Implementation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Medical Research Future Fund, Metro South Health, Metro North Health, Queensland University of Technology, University of Sydney, OPN365, Australian Dementia Network, Dementia Australia, Lions Club of Brisbane Inner North, Parkinson's Queensland
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDCogniCare | Other | Other: PDCogniCare platformAll eligible people living with Parkinson's disease who consent to participate will be registered into the PDCogniCare platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People living with idiopathic Parkinson's disease, one year or more post-diagnosis, attending Movement Disorder Clinics
Key exclusion criteria (2 listed)
- People with severe Parkinson's disease who aren't able to communicate
- People with comorbid neurological conditions (e.g. Stroke)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDCogniCare platformDigital platform designed to support early and accurate detection of dementia in people living with Parkinson's disease | Other | PDCogniCare |
Primary outcome
Change in percentage of people with Parkinson's disease diagnosed with dementia
Time frame: 12 months from enrolment
1 secondary outcome
Change in percentage of people with Parkinson's disease diagnosed with mild cognitive impairment
Time frame: 12 months from enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 40464273Pourzinal 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.
- Background: PubMed 40360335Pourzinal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiffany Au contact
Questions about this trial
What is this clinical trial studying?
A study testing PDCogniCare platform in people with Dementia (Diagnosis) and Parkinson Disease Dementia (PDD), run by The University of Queensland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadeeka Dissanayaka (+617 3346 5577, pdcognicare@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage of people with Parkinson's disease diagnosed with dementia (time frame: 12 months from enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07114354, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.