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Neuropsychological Evaluation for Early Diagnosis of PSP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03478124
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ospedale Generale Di Zona Moriggia-Pelascini

Brief 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.

Condition or disease Intervention/treatment
Progressive Supranuclear Palsy Cognitive Impairment Behavioral: Cognitive evaluation

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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Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Role of the Neuropsychological Evaluation for Early Diagnosis of Progressive Supranuclear Palsy
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 2, 2018


Group/Cohort Intervention/treatment
PSP patients
Patients suffering from Progressive Supranuclear Palsy (PSP)
Behavioral: Cognitive 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.

PD Patients
Patients suffering from Parkinson's disease (PD)
Behavioral: Cognitive 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478124


Sponsors and Collaborators
Ospedale Generale Di Zona Moriggia-Pelascini
Investigators
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Principal Investigator: Giuseppe Frazzitta, MD Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy

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Responsible Party: Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier: NCT03478124    
Other Study ID Numbers: NPsy-PSP
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Supranuclear Palsy, Progressive
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms