Progressive Supranuclear PalsyNCT03478124
Neuropsychological Evaluation for Early Diagnosis of PSP
An observational study of Progressive Supranuclear Palsy and Cognitive Impairment, run by Ospedale Generale Di Zona Moriggia-Pelascini.
Trial summary
The aim of this study is to better understand the nature of the cognitive decline in Progressive Supranuclear Palsy, the time of its development and the relation with the other cardinal features of the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Progressive Supranuclear Palsy, Cognitive Impairment
- What is being tested?
- Cognitive evaluation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 2 Mar 2018
- 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 Any age
- Child, Adult, Older adult
Study population: 56 PSP patients (PSPp) and 56 PD patients (PDp) were enrolled and matched for sex, age and disease duration.
Who may be able to join
- Patients fulfilling the criteria for idiopathic PD
- Patients fulfilling the criteria for PSP
Who cannot join
- Any other neurodegenerative disorders or medical conditions different from PD / PSP
About this study
Official title: The Role of the Neuropsychological Evaluation for Early Diagnosis of Progressive Supranuclear Palsy
The aim of this study is to better understand the nature of the cognitive decline in Progressive Supranuclear Palsy, the time of its development and the relation with the other cardinal features of the disease.
Read the detailed description
Progressive Supranuclear Palsy (PSP) is a neurodegenerative disease characterized by vertical supranuclear gaze palsy, early balance dysfunction and falls. Tau-protein aggregation, mainly in the brainstem, is the disease hallmark. Because of the similarities with Parkinson's disease (PD), the diagnosis is made approximately 4 years after the symptoms onset. Cognitive deficits are a leading feature of PSP and they actually represent one of the four functional core domains in the revised diagnostic criteria. The aim of this study is to better understand the nature of this cognitive decline, the time of its development and the relation with the other cardinal features of the disease.
- Being tested
- Cognitive evaluation
- Medical subject headings
- Supranuclear Palsy, Progressive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive evaluationBehavioural
An extensive battery of neuropsychological and motor tests was assessed: MMSE, FAB, MoCA, WCST, Stroop Test, TMT-A and B, Verbal fluency Test, ROCF copy and delayed recall, RAVLT, 6MWT, TUG, BBS.
| Study group | Role | What they receive |
|---|---|---|
| PSP patients | Patients suffering from Progressive Supranuclear Palsy (PSP) Receives: Behavioral: Cognitive evaluation | |
| PD Patients | Patients suffering from Parkinson's disease (PD) Receives: Behavioral: Cognitive evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
Mini-Mental State Examination
Measured: 1 year
FAB
Frontal Assessment Battery
Measured: 1 year
MoCA
Montreal Cognitive Assessment
Measured: 1 year
WCST
Wisconsin Card Sorting Test
Measured: 1 year
ST
Stroop Test
Measured: 1 year
TMT-A and B
Trail Making Test Parts A \& B
Measured: 1 year
VFT
Verbal fluency Test
Measured: 1 year
ROCF copy and delayed recall
Rey-Osterrieth complex figure test copy and delayed recall
Measured: 1 year
RAVLT
Rey Auditory Verbal Learning Test
Measured: 1 year
Secondary outcomes (3)
6MWT
6 Minute Walk Test
Measured: 1 year
TUG
Timed Up and Go Test
Measured: 1 year
BBS
Berg Balance Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Jan 2016
- Primary completion1 Mar 2018
- Study completion2 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478124
- Sponsor's protocol ID
- NPsy-PSP
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Neuropsychological Evaluation for Early Diagnosis of Progressive Supranuclear Palsy
- ClinicalTrials.gov ID
- NCT03478124
- Acronym / sponsor ID
- NPsy-PSP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 27 Mar 2018 (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 aim of this study is to better understand the nature of the cognitive decline in Progressive Supranuclear Palsy, the time of its development and the relation with the other cardinal features of the disease.
Detailed description
Progressive Supranuclear Palsy (PSP) is a neurodegenerative disease characterized by vertical supranuclear gaze palsy, early balance dysfunction and falls. Tau-protein aggregation, mainly in the brainstem, is the disease hallmark. Because of the similarities with Parkinson's disease (PD), the diagnosis is made approximately 4 years after the symptoms onset. Cognitive deficits are a leading feature of PSP and they actually represent one of the four functional core domains in the revised diagnostic criteria. The aim of this study is to better understand the nature of this cognitive decline, the time of its development and the relation with the other cardinal features of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSP patients | – | Behavioral: Cognitive evaluationPatients suffering from Progressive Supranuclear Palsy (PSP) |
| PD Patients | – | Behavioral: Cognitive evaluationPatients suffering from Parkinson's disease (PD) |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- 56 PSP patients (PSPp) and 56 PD patients (PDp) were enrolled and matched for sex, age and disease duration.
Key inclusion criteria (2 listed)
- Patients fulfilling the criteria for idiopathic PD
- Patients fulfilling the criteria for PSP
Key exclusion criteria (1 listed)
- Any other neurodegenerative disorders or medical conditions different from PD / PSP
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 |
|---|---|---|
| Cognitive evaluationAn extensive battery of neuropsychological and motor tests was assessed: MMSE, FAB, MoCA, WCST, Stroop Test, TMT-A and B, Verbal fluency Test, ROCF copy and delayed recall, RAVLT, 6MWT, TUG, BBS. | Behavioural | PD Patients, PSP patients |
Primary outcome
MMSE
Time frame: 1 year
Mini-Mental State Examination
FAB
Time frame: 1 year
Frontal Assessment Battery
MoCA
Time frame: 1 year
Montreal Cognitive Assessment
WCST
Time frame: 1 year
Wisconsin Card Sorting Test
ST
Time frame: 1 year
Stroop Test
TMT-A and B
Time frame: 1 year
Trail Making Test Parts A \& B
VFT
Time frame: 1 year
Verbal fluency Test
ROCF copy and delayed recall
Time frame: 1 year
Rey-Osterrieth complex figure test copy and delayed recall
RAVLT
Time frame: 1 year
Rey Auditory Verbal Learning Test
3 secondary outcomes
6MWT
Time frame: 1 year
TUG
Time frame: 1 year
BBS
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Giuseppe Frazzitta, MD principal investigator
Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Supranuclear Palsy and Cognitive Impairment, run by Ospedale Generale Di Zona Moriggia-Pelascini.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2018.