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Imaging Characteristics of a Follow-up 18F-AV-1451 Scan

Primary Purpose

Alzheimer's Disease

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Flortaucipir F18

Florbetapir F 18

Brain PET Scan

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Have a previous 18F-AV-1451 brain scan
Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan
Ability to provide informed consent

Exclusion Criteria:

Current clinically significant psychiatric disease
Are claustrophobic
Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session

Sites / Locations

Hoag Memorial Hospital
UC Irvine Medical Center
Massachusetts General Hospital
Center for Clinical Imaging Research, Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Follow-up Flortaucipir PET Scan

Arm Description

Outcomes

Primary Outcome Measures

Change in Tau Deposition

Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Secondary Outcome Measures

Full Information

NCT ID

NCT02051764

First Posted

January 30, 2014

Last Updated

September 3, 2020

Sponsor

Avid Radiopharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02051764

Brief Title

Imaging Characteristics of a Follow-up 18F-AV-1451 Scan

Official Title

An Open Label, Multicenter Study, Evaluating the Imaging Characteristics of a Follow-up 18F-AV-1451 Scan in Subjects Who Have Had a Prior 18F-AV-1451 Scan

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Terminated

Why Stopped

Lower than expected enrollment

Study Start Date

May 2014 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Avid Radiopharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Follow-up Flortaucipir PET Scan

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Flortaucipir F18

Other Intervention Name(s)

18F-AV-1451, LY3191748, [F-18]T807

Intervention Description

370 megabecquerel (MBq) IV single-dose

Intervention Type

Drug

Intervention Name(s)

Florbetapir F 18

Other Intervention Name(s)

Amyvid, 18F-AV-45

Intervention Description

370 megabecquerel (MBq) IV single-dose

Intervention Type

Procedure

Intervention Name(s)

Brain PET Scan

Intervention Description

positron emission tomography (PET) scan of the brain

Primary Outcome Measure Information:

Title

Change in Tau Deposition

Description

Time Frame

baseline scan and at least 6 months after baseline scan

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a previous 18F-AV-1451 brain scan Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan Ability to provide informed consent Exclusion Criteria: Current clinically significant psychiatric disease Are claustrophobic Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chief Medical Officer

Organizational Affiliation

Avid Radiopharmaceuticals, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Hoag Memorial Hospital

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

UC Irvine Medical Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Center for Clinical Imaging Research, Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Imaging Characteristics of a Follow-up 18F-AV-1451 Scan

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