NCT02051764

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2014

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

September 7, 2020

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

2.6 years

First QC Date

January 30, 2014

Results QC Date

June 27, 2020

Last Update Submit

September 3, 2020

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline scan and at least 6 months after baseline scan

Study Arms (1)

Follow-up Flortaucipir PET Scan

EXPERIMENTAL
Drug: Flortaucipir F18Drug: Florbetapir F 18Procedure: Brain PET Scan

Interventions

Flortaucipir F18DRUG

370 megabecquerel (MBq) IV single-dose

Also known as: 18F-AV-1451, LY3191748, [F-18]T807
Follow-up Flortaucipir PET Scan
Florbetapir F 18DRUG

370 megabecquerel (MBq) IV single-dose

Also known as: Amyvid, 18F-AV-45
Follow-up Flortaucipir PET Scan
Brain PET ScanPROCEDURE

positron emission tomography (PET) scan of the brain

Follow-up Flortaucipir PET Scan

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Center for Clinical Imaging Research, Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indoleflorbetapir

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Medical Director
Organization
Avid Radiopharmaceuticals, Inc.
clinicaloperations@avidrp.com
215-298-0700

Study Officials

  • Chief Medical Officer

    Avid Radiopharmaceuticals, Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

January 31, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 7, 2020

Results First Posted

September 7, 2020

Record last verified: 2020-09

Locations

US(4)