Cognitive Impairement In Frontotemporal Dementia

November 10, 2020 updated by: University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
997

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
FTD Cohort
No intervention-observation only
Other: None-Observation Only
No intervention-this is an observational study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impaired semantic memory in Semantic Dementia (SD).
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
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effortful speech in Progressive Nonfluent Aphasia (PNFA)
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
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
Social disinhibition and rule violation in FTD
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 298201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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