Tau Imaging in Young Onset Dementia | NCT02289118

Studies
Tau Imaging in Young Onset Dementia

NCT02289118

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Mar 25, 2020Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Alzheimer's Disease, Early Onset
Logopenic Progressive Aphasia
Posterior Cortical Atrophy (PCA)

Interventions

[18F]-T807 imaging tracer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Dec 2018Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Nov 5, 2014

First Submission Date that Met QC Criteria

Nov 7, 2014

First Posted Date

Nov 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2020

Last Update Posted Date

Mar 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The central goal of this study is to determine and compare the similarities and differences in regional brain uptake of [18F]T807 in patients with typical Alzheimer's Disease (AD), Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia (lvPPA). The investigators will correlate patterns of [18F]T807 binding with magnetic resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20 participants, 45-70 years old, with clinical evidence of young onset focal dementia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Label	Type	Description	Intervention Names
Diagnostic Imaging		[18F]T807 imaging tracer.	Drug: [18F]-T807 imaging tracer

Name	Type	Description	Arm Group Labels	Other Names
[18F]-T807 imaging tracer	Drug	Tau Imaging tracer	Diagnostic Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine and compare the similarities and differences in regional brain uptake of [18F]T807 by using standardized uptake value ratio (SUVr) in patients with typical AD, PCA and lvPPA		2 years
Correlate patterns of [18F]T807 binding based on standardized uptake value ratio (SUVr) with MRI-based regional volumetric (mm3) and cortical thickness (mm) measures		2 years

Secondary Outcomes

Measure	Description	Time Frame
Correlate CSF markers of amyloid (Aβ1-42) and/or tau (total tau, phospho-tau) pathology (pg/mL) to uptake of [18F]T807 based on standardized uptake value ratio (SUVr).		2 years
Correlate [18F]T807 binding based on standardized uptake value ratio (SUVr) with standard cognitive tests.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants will be 45 - 70 years of age
MMSE > 10 at screening visit.
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent.
Participants must be willing and able to comply with scheduled visits and imaging procedures.
A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI either as a part of this study
Participants must identify a study partner who is willing to accompany the patient to study visits

Exclusion Criteria:

Females who are pregnant or breast feeding at the time of screening scan will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening
Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician
QTc > 450 msec on screening ECG.
Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study (e.g. moderate to large stroke or history of moderate or severe traumatic brain injury (TBI)).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Participants with early onset AD (symptoms preceding age 65)

Sampling Method

Non-Probability Sample

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases