Neuropsychological Evaluation for Early Diagnosis of PSP

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478124
• Other study ID #: NPsy-PSP
• Status: Completed
• First received: March 20, 2018
• Last updated: March 20, 2018
• Start date: January 1, 2016
• Est. completion date: March 2, 2018

Study information

• Verified date: March 2018
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2, 2018
• Est. primary completion date: March 1, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMSE	Mini-Mental State Examination	1 year
Primary	FAB	Frontal Assessment Battery	1 year
Primary	MoCA	Montreal Cognitive Assessment	1 year
Primary	WCST	Wisconsin Card Sorting Test	1 year
Primary	ST	Stroop Test	1 year
Primary	TMT-A and B	Trail Making Test Parts A & B	1 year
Primary	VFT	Verbal fluency Test	1 year
Primary	ROCF copy and delayed recall	Rey-Osterrieth complex figure test copy and delayed recall	1 year
Primary	RAVLT	Rey Auditory Verbal Learning Test	1 year
Secondary	6MWT	6 Minute Walk Test	1 year
Secondary	TUG	Timed Up and Go Test	1 year
Secondary	BBS	Berg Balance Scale	1 year