ClinicalTrials.gg
CompletedNCT03452956Updated Nov 12, 2020

Cognitive Impairement In Frontotemporal Dementia

An observational study in Frontotemporal Degeneration, Progressive Supranuclear Palsy and Multiple System Atrophy, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-12.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
997
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 84 studies in Supranuclear Palsy, Progressive with a site in United States — 19 open to participants now, 26 under way, 1 of them phase 3. Supranuclear Palsy, Progressive · United States.

Enrollment
8th of 31
997 · median 200
Started
2003
the only one that year
Observational
31 of 84
10 open now
Registered
47th of 84
by date
Lead sponsor
5 of 84
University of Pennsylvania

Among the 84 studies in Supranuclear Palsy, Progressive with a site in United States, this one is the 8th largest by enrollment of the 31 observational ones that give a count, is the only one that started in 2003, is one of 31 observational ones, and was the 47th registered.

Supranuclear Palsy, Progressive

171 studies on the registry are indexed under Supranuclear Palsy, Progressive; 51 are open to participants now.

Browse Supranuclear Palsy, Progressive studies →

Open to participants now

19 of the 84 studies in Supranuclear Palsy, Progressive with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 19 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 38 Supranuclear Palsy, Progressive studies recruiting now, 22 (58%) set no upper age limit and 2 (5%) stop at 75 or younger; 5 take children under 18; 14 take healthy volunteers.

This study: 18 Years and older · all sexes.

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02

Study 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.

Read the detailed 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.

03

Conditions studied

  • Frontotemporal Degeneration
  • Progressive Supranuclear Palsy
  • Multiple System Atrophy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All individuals with a diagnosis of FTD, PSP, or MSA, previously identified by the PI and sub-investigators through other FTD studies (protocol number 702681) and through the PI's extensive FTD clinical practice at the University of Pennsylvania and at Pennsylvania Hospital's Department of Neurology, will be recruited through letters, brochures, and study flyers.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals who have been diagnosed with FTD, PSP, and MSA

Exclusion criteria

Exclusion Criteria:

  • Individuals under 18 years of age
  • People with pacemakers or certain metallic implants
  • pregnant women
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
997 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • FTD Cohort

    No intervention-observation only

    Other: None-Observation Only

Interventions

  • OtherNone-Observation Only

    No intervention-this is an observational study

06

What researchers measure

Primary outcomes

  1. Progression

    Changes over time in MRI and cognitive testing data.

    Time frame: 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 outcomes

  1. Impaired semantic memory in Semantic Dementia (SD).

    The impact of cortical atrophy on language processing.

    Time frame: 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 outcomes

  1. Effortful speech in Progressive Nonfluent Aphasia (PNFA)

    Speech samples related to cortical atrophy seen on MRI and fMRI studies of verb past tense inflection.

    Time frame: 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

  2. Social disinhibition and rule violation in FTD

    Relationship of cognitive testing and MRI data and changes over time.

    Time frame: 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

07

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Individual participant data

Plan to share: Yes — The University of Pennsylvania is a participant in the National Alzheimer's Coordinating Center 's FTLD-NACC initiative to create a national database of data specific to FTD spectrum diseases.The FTLD NACC initiative will enable research centers focusing on FTD spectrum diseases to gather standardized data on their FTLD patients, all of which will be combined into a single database and made freely available to researchers around the world. The FTLD-NACC collects data standardly obtained in this study, including neurocognitive assessments, MRI imaging data, and biomarkers collected through lumbar puncture and blood draw.The FTLD-NACC is designed to facilitate collaborative research and will allow researchers to maximize the use of clinical information and biological material available on frontotemporal degenerative spectrum diseases. Subjects will be able to choose whether or not their research data is shared with the FTD-NACC.

Time frame: As this is an ongoing, longitudinal study, IPD will be available through the duration of the study.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2003 to primary completion in Jul 2020, 204 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2018
First posted
Mar 2, 2018
StartActual
Jul 1, 2003
Primary completionActual
Jul 15, 2020
CompletionActual
Jul 15, 2020
Last update
Nov 12, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03452956
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Jul 1, 2003
Primary completion
Jul 15, 2020
Completion
Jul 15, 2020
Last update
Nov 12, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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