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NCT Number: NCT03478124

Neuropsychological Evaluation for Early Diagnosis of PSP

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.

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Key information

Conditions

Progressive Supranuclear Palsy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Cranial Nerve Diseases Eye Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Supranuclear Palsy, Progressive Tauopathies

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cognitive evaluation

Behavioral

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.

Primary outcomes

  1. MMSE

    Time frame: 1 year

    Mini-Mental State Examination

  2. FAB

    Time frame: 1 year

    Frontal Assessment Battery

  3. MoCA

    Time frame: 1 year

    Montreal Cognitive Assessment

  4. WCST

    Time frame: 1 year

    Wisconsin Card Sorting Test

  5. ST

    Time frame: 1 year

    Stroop Test

  6. TMT-A and B

    Time frame: 1 year

    Trail Making Test Parts A & B

  7. VFT

    Time frame: 1 year

    Verbal fluency Test

  8. ROCF copy and delayed recall

    Time frame: 1 year

    Rey-Osterrieth complex figure test copy and delayed recall

  9. RAVLT

    Time frame: 1 year

    Rey Auditory Verbal Learning Test

Secondary outcomes

  1. 6MWT

    Time frame: 1 year

    6 Minute Walk Test

  2. TUG

    Time frame: 1 year

    Timed Up and Go Test

  3. BBS

    Time frame: 1 year

    Berg Balance Scale

Sponsors and collaborators

Lead sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Other

Registry information

Official study title

The Role of the Neuropsychological Evaluation for Early Diagnosis of Progressive Supranuclear Palsy

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2018
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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