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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03452956
Other study ID # 298201
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2003
Est. completion date July 15, 2020

Study information

Verified date November 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational study that aims to better understand the genetic causes of frontotemporal degeneration (FTD), Multiple Systems Atrophy (MSA), and Progressive Supranuclear Palsy (PSP). It is hoped the information gathered in this study will help lead to better diagnostics and future treatments.


Description:

Comparative and longitudinal studies reveal clinical differences between subgroups of patients with frontotemporal dementia (FTD), including Progressive Non-fluent Aphasia (PNFA), Semantic Dementia (SD), patients with a disorder of social comportment and personality (SOC), and non-aphasic patients with executive dysfunction (EXEC). MRI studies of cortical atrophy and fMRI studies show correlated neural defects in FTD subgroups. The investigators will obtain converging evidence from multiple sources to test hypotheses about the neural basis for cognitive functions such as semantic memory, grammatical processing, and social functioning in these FTD subgroups, while improving clinical care for these patients. Recent studies have linked progressive supra nuclear palsy (PSP) and multiple systems atrophy (MSA) to FTD. The investigators will obtain comparable neuropsychological and biomarker data in order to compare these patient groups.


Recruitment information / eligibility

Status Completed
Enrollment 997
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Individuals who have been diagnosed with FTD, PSP, and MSA Exclusion Criteria: - Individuals under 18 years of age - People with pacemakers or certain metallic implants - pregnant women

Study Design


Intervention

Other:
None-Observation Only
No intervention-this is an observational study

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Effortful speech in Progressive Nonfluent Aphasia (PNFA) Speech samples related to cortical atrophy seen on MRI and fMRI studies of verb past tense inflection. This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed
Other Social disinhibition and rule violation in FTD Relationship of cognitive testing and MRI data and changes over time. This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed
Primary Progression Changes over time in MRI and cognitive testing data. This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed
Secondary Impaired semantic memory in Semantic Dementia (SD). The impact of cortical atrophy on language processing. This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed
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