Parkinson DiseaseNEUROFINNCT05791006
Neuropsychology of Financial Capacity
An observational study of Parkinson Disease and Brain Tumor, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The present project aims to investigate the financial capacity in patients diagnosed with Parkinson's Disease or parkinsonism, brain tumor (glioma or meningioma) and cerebrovascular lesion (stroke), in order to evaluate the presence and degree of impairment, and the role of some factors as potential predictors of… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Brain Tumor, Stroke
- What is being tested?
- Neuropsychological tests
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- 4 Aug 2021to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients with Parkinson's Disease/parkinsonisms * Patients with brain tumor * Patients with stroke * Healthy controls
Who may be able to join
- age > 18 years
- Clinical diagnosis of interest for clinical groups
- For stroke patients: disease duration > 1 month
Who cannot join
- Other brain disorders different from those of interest
- Sensory-motor deficits that could prevent neuropsychological assessment
- Language disorders that could prevent neuropsychological assessment
- Global cognitive impairment as indexed by MoCA < 26 or MMP < 22.85
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, Lombardy, 20122
Nadia Bolognini, PhD, +39025821 ext. 8132, n.bolognini@auxologico.it
About this study
The present project aims to investigate the financial capacity in patients diagnosed with Parkinson's Disease or parkinsonism, brain tumor (glioma or meningioma) and cerebrovascular lesion (stroke), in order to evaluate the presence and degree of impairment, and the role of some factors as potential predictors of financial incapacity.
The term 'financial capacity' means both operations relating, for example, to asset management or investing money, and activities of daily life such as shopping or using small sums of money; these activities are mediated by different cognitive functions, from numerical and arithmetic skills to decision making. Financial capacity is, in fact, an instrumental activity of daily life (i.e. Instrumental Activity Of Daily Living, I-ADL) whose impairment negatively affects the functional autonomy of the individual, so as to be subject to legal protection.
To assess financial capacity, the Numerical Activities of Daily Living - Financial (NADL-F; Arcara et al., 2017) will be administered, a battery of tests aimed at investigating both financial performance and financial competence according to the most recent neuropsychological models proposed in the literature.
- Conditions
- Parkinson Disease, Brain Tumor, Stroke
- Being tested
- Neuropsychological tests
- Medical subject headings
- Parkinson Disease, Brain Neoplasms, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsBehavioural
Neuropsychological assessment with:
- NADL-F
- Frontal Assessment Battery (FAB)
- functional scales assessing activities of daily living (ADL) and instrumental activities of daily living (I-ADL)
- Mini-Mental Parkinson (MMP) - For Parkinson's Disease patients
- Montreal Cognitive Assessment (MoCA) - for brain tumor and stroke patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's Disease/Parkinsonisms | Not described Receives: Behavioral: Neuropsychological tests | |
| Patients with brain tumors | Not described Receives: Behavioral: Neuropsychological tests | |
| Patients with ischemic or haemorrhagic stroke | Not described Receives: Behavioral: Neuropsychological tests | |
| Healthy Controls | Not described Receives: Behavioral: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Activity of Daily Living Financial (NADL-F) in Patients with Parkinson's Disease/Parkinsonisms
Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities
Measured: At baseline
Numerical Activity of Daily Living Financial (NADL-F) in Patients with ischemic or haemorrhagic stroke
Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities
Measured: At baseline
Change from baseline in Numerical Activity of Daily Living - Financial (NADL-F)Patients with brain tumors
Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities
Measured: At 3 and 12 months follow up
Montreal Cognitive Assessment (MoCA)
Assessment of global cognitive functioning
Measured: At baseline
Frontal Assessment Battery (FAB)
Assessment of global cognitive functioning
Measured: At baseline
Activities of daily living questionnaire (ADL)
Assessment of function independence in everyday life
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start4 Aug 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791006
- Sponsor's protocol ID
- 25C121
- Acronym
- NEUROFIN
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arcara G, Burgio F, Benavides-Varela S, Toffano R, Gindri P, Tonini E, Meneghello F, Semenza C. Numerical Activities of Daily Living - Financial (NADL-F): A tool for the assessment of financial capacities double dagger. Neuropsychol Rehabil. 2019 Aug;29(7):1062-1084. doi: 10.1080/09602011.2017.1359188. Epub 2017 Sep 7.
PubMed 28880732
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychology of Financial Capacity
- ClinicalTrials.gov ID
- NCT05791006
- Acronym / sponsor ID
- NEUROFIN / 25C121
- Conditions
- Parkinson Disease, Brain Tumor, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 30 Mar 2023 (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.
The present project aims to investigate the financial capacity in patients diagnosed with Parkinson's Disease or parkinsonism, brain tumor (glioma or meningioma) and cerebrovascular lesion (stroke), in order to evaluate the presence and degree of impairment, and the role of some factors as potential predictors of financial incapacity.
The term 'financial capacity' means both operations relating, for example, to asset management or investing money, and activities of daily life such as shopping or using small sums of money; these activities are mediated by different cognitive functions, from numerical and arithmetic skills to decision making. Financial capacity is, in fact, an instrumental activity of daily life (i.e. Instrumental Activity Of Daily Living, I-ADL) whose impairment negatively affects the functional autonomy of the individual, so as to be subject to legal protection.
To assess financial capacity, the Numerical Activities of Daily Living - Financial (NADL-F; Arcara et al., 2017) will be administered, a battery of tests aimed at investigating both financial performance and financial competence according to the most recent neuropsychological models proposed in the literature.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's Disease/Parkinsonisms | – | Behavioral: Neuropsychological tests |
| Patients with brain tumors | – | Behavioral: Neuropsychological tests |
| Patients with ischemic or haemorrhagic stroke | – | Behavioral: Neuropsychological tests |
| Healthy Controls | – | Behavioral: Neuropsychological tests |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with Parkinson's Disease/parkinsonisms * Patients with brain tumor * Patients with stroke * Healthy controls
Key inclusion criteria (3 listed)
- age > 18 years
- Clinical diagnosis of interest for clinical groups
- For stroke patients: disease duration > 1 month
Key exclusion criteria (4 listed)
- Other brain disorders different from those of interest
- Sensory-motor deficits that could prevent neuropsychological assessment
- Language disorders that could prevent neuropsychological assessment
- Global cognitive impairment as indexed by MoCA < 26 or MMP < 22.85
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 |
|---|---|---|
| Neuropsychological testsNeuropsychological assessment with: * NADL-F * Frontal Assessment Battery (FAB) * functional scales assessing activities of daily living (ADL) and instrumental activities of daily living (I-ADL) * Mini-Mental Parkinson (MMP) - For Parkinson's Disease patients * Montreal Cognitive Assessment (MoCA) - for brain tumor and stroke patients | Behavioural | Healthy Controls, Patients with Parkinson's Disease/Parkinsonisms, Patients with brain tumors, Patients with ischemic or haemorrhagic stroke |
Primary outcome
Numerical Activity of Daily Living Financial (NADL-F) in Patients with Parkinson's Disease/Parkinsonisms
Time frame: At baseline
Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities
Numerical Activity of Daily Living Financial (NADL-F) in Patients with ischemic or haemorrhagic stroke
Time frame: At baseline
Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities
Change from baseline in Numerical Activity of Daily Living - Financial (NADL-F)Patients with brain tumors
Time frame: At 3 and 12 months follow up
Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities
Montreal Cognitive Assessment (MoCA)
Time frame: At baseline
Assessment of global cognitive functioning
Frontal Assessment Battery (FAB)
Time frame: At baseline
Assessment of global cognitive functioning
Activities of daily living questionnaire (ADL)
Time frame: At baseline
Assessment of function independence in everyday life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Background: PubMed 28880732Arcara G, Burgio F, Benavides-Varela S, Toffano R, Gindri P, Tonini E, Meneghello F, Semenza C. Numerical Activities of Daily Living - Financial (NADL-F): A tool for the assessment of financial capacities double dagger. Neuropsychol Rehabil. 2019 Aug;29(7):1062-1084. doi: 10.1080/09602011.2017.1359188. Epub 2017 Sep 7.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Brain Tumor, run by Istituto Auxologico Italiano at 1 site in Italy.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia Bolognini, PhD (+39025821 ext. 8132, n.bolognini@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Activity of Daily Living Financial (NADL-F) in Patients with Parkinson's Disease/Parkinsonisms (time frame: At baseline). The study lists 6 primary outcomes in all. 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 NCT05791006, which also lists 1 linked publication.
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 30 Mar 2023.