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Tau PET Imaging in Atypical Dementias

Primary Purpose

Primary Progressive Aphasia With Suspected Alzheimer's Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-AV-1451
PET
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Progressive Aphasia With Suspected Alzheimer's Disease

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have primary progressive aphasia

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Receiving radiation clinically

Sites / Locations

  • Cognitive Neurology and Alzheimer's Disease Center - Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AV-1451 Recipients

Arm Description

Participants in this arm of the study will all receive an injection of 10 Mci of AV-1451 and then be scanned in a PET scanner for brain imaging.

Outcomes

Primary Outcome Measures

Tau levels in PPA participants
Tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) in cortical and medial temporal regions.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2016
Last Updated
October 4, 2022
Sponsor
Northwestern University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03283449
Brief Title
Tau PET Imaging in Atypical Dementias
Official Title
Tau PET Imaging in Atypical Dementias
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute on Aging (NIA)

4. Oversight

5. Study Description

Brief Summary
The goal of this study is to demonstrate the feasibility of mapping tau pathology in subjects with Primary Progressive Aphasia, using PET protocol with F-AV-1451 (trade name AV-1451) and to systematically document the extent and location of tau pathology in PPA patients in vivo using the same techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Aphasia With Suspected Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AV-1451 Recipients
Arm Type
Experimental
Arm Description
Participants in this arm of the study will all receive an injection of 10 Mci of AV-1451 and then be scanned in a PET scanner for brain imaging.
Intervention Type
Drug
Intervention Name(s)
18F-AV-1451
Other Intervention Name(s)
AV-1451
Intervention Type
Device
Intervention Name(s)
PET
Intervention Description
PET scanner for brain imaging
Primary Outcome Measure Information:
Title
Tau levels in PPA participants
Description
Tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) in cortical and medial temporal regions.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have primary progressive aphasia Exclusion Criteria: Pregnancy Breastfeeding Receiving radiation clinically
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyi Adeolu
Phone
312-503-2398
Email
PPA.Research@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Rogalski, Ph.D.
Phone
312-503-1155
Email
erogalski@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Rogalski, Ph.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cognitive Neurology and Alzheimer's Disease Center - Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seyi Adeolu
Phone
312-503-2398
Email
PPA.Research@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Emily Rogalski, Ph.D.
Phone
312-503-1155
Email
erogalski@gmail.com
First Name & Middle Initial & Last Name & Degree
Emily Rogalski, Ph.D.

12. IPD Sharing Statement

Links:
URL
https://www.brain.northwestern.edu/join/index.html
Description
PPA Research at Northwestern University

Learn more about this trial

Tau PET Imaging in Atypical Dementias

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