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CompletedNCT03478124Updated Mar 27, 2018

Neuropsychological Evaluation for Early Diagnosis of PSP

An observational study in Progressive Supranuclear Palsy and Cognitive Impairment, sponsored by Ospedale Generale Di Zona Moriggia-Pelascini. Completed. Per ClinicalTrials.gov, last updated 2018-03-27.

Sponsored by Ospedale Generale Di Zona Moriggia-Pelascini · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
112
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Study 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 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.

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Conditions studied

  • Progressive Supranuclear Palsy
  • Cognitive Impairment
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In context

Supranuclear Palsy, Progressive

171 studies on the registry are indexed under Supranuclear Palsy, Progressive; 51 are open to participants now.

This study's enrollment of 112 is below the median of 200 across 66 observational studies indexed under Supranuclear Palsy, Progressive.

Browse Supranuclear Palsy, Progressive studies →

Lead sponsor

Ospedale Generale Di Zona Moriggia-Pelascini is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sampling method
Probability sample

Study population

56 PSP patients (PSPp) and 56 PD patients (PDp) were enrolled and matched for sex, age and disease duration.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients fulfilling the criteria for idiopathic PD
  • Patients fulfilling the criteria for PSP

Exclusion criteria

Exclusion Criteria:

  • Any other neurodegenerative disorders or medical conditions different from PD / PSP
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
112 participants (actual)
Patient registry
No

Groups and cohorts

  • PSP patients

    Patients suffering from Progressive Supranuclear Palsy (PSP)

    Behavioral: Cognitive evaluation

  • PD Patients

    Patients suffering from Parkinson's disease (PD)

    Behavioral: Cognitive evaluation

Interventions

  • BehavioralCognitive evaluation

    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.

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What researchers measure

Primary outcomes

  1. MMSE

    Mini-Mental State Examination

    Time frame: 1 year

  2. FAB

    Frontal Assessment Battery

    Time frame: 1 year

  3. MoCA

    Montreal Cognitive Assessment

    Time frame: 1 year

  4. WCST

    Wisconsin Card Sorting Test

    Time frame: 1 year

  5. ST

    Stroop Test

    Time frame: 1 year

  6. TMT-A and B

    Trail Making Test Parts A \& B

    Time frame: 1 year

  7. VFT

    Verbal fluency Test

    Time frame: 1 year

  8. ROCF copy and delayed recall

    Rey-Osterrieth complex figure test copy and delayed recall

    Time frame: 1 year

  9. RAVLT

    Rey Auditory Verbal Learning Test

    Time frame: 1 year

Secondary outcomes

  1. 6MWT

    6 Minute Walk Test

    Time frame: 1 year

  2. TUG

    Timed Up and Go Test

    Time frame: 1 year

  3. BBS

    Berg Balance Scale

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Mar 2018, 26 months.

Of 37 observational studies under Supranuclear Palsy, Progressive, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 54. This study's 26 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2018
First posted
Mar 27, 2018
StartActual
Jan 1, 2016
Primary completionActual
Mar 1, 2018
CompletionActual
Mar 2, 2018
Last update
Mar 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03478124
Lead sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Jan 1, 2016
Primary completion
Mar 1, 2018
Completion
Mar 2, 2018
Last update
Mar 27, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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