NCT03478124

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

March 20, 2018

Last Update Submit

March 20, 2018

Conditions

Outcome Measures

Primary Outcomes (9)

  • MMSE

    Mini-Mental State Examination

    1 year

  • FAB

    Frontal Assessment Battery

    1 year

  • MoCA

    Montreal Cognitive Assessment

    1 year

  • WCST

    Wisconsin Card Sorting Test

    1 year

  • ST

    Stroop Test

    1 year

  • TMT-A and B

    Trail Making Test Parts A \& B

    1 year

  • VFT

    Verbal fluency Test

    1 year

  • ROCF copy and delayed recall

    Rey-Osterrieth complex figure test copy and delayed recall

    1 year

  • RAVLT

    Rey Auditory Verbal Learning Test

    1 year

Secondary Outcomes (3)

  • 6MWT

    1 year

  • TUG

    1 year

  • BBS

    1 year

Study Arms (2)

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

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 PatientsPSP patients

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Supranuclear Palsy, ProgressiveCognitive Dysfunction

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 27, 2018

Study Start

January 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 2, 2018

Last Updated

March 27, 2018

Record last verified: 2018-03