NCT02707978

Brief Summary

The purpose of this research study is to evaluate tau distribution in the brain of subjects with: FTD caused by different genetic mutations, any mutation carriers (with or without symptoms), any non-mutation carrier, any sporadic FTD, normal controls.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Typical duration for phase_2 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 7, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 30, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

April 7, 2015

Last Update Submit

March 11, 2024

Conditions

Alzheimer Disease

Keywords

DementiaBrain DiseasesCentral Nervous System DiseasesMild Cognitive ImpairmenttauopathiesNeurodegenerative Disease

Outcome Measures

Primary Outcomes (1)

  • F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.

    5 years

Study Arms (1)

Experimental F 18 T807

EXPERIMENTAL
Drug: F 18 T807

Interventions

F 18 T807DRUG

Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.

Also known as: 18F-AV-1451
Experimental F 18 T807

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female participants, at least 18 years of age.
  • Clinically diagnosed with frontotemporal dementia (FTD), or a carrier of a mutation known to cause FTD (with or without symptoms); or a normal control.
  • Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
  • Pre-menopausal women will have a negative a urine pregnancy test within 24 hours of T807 drug administration.

You may not qualify if:

  • Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
  • Is deemed likely unable to perform the imaging procedures for any reason.
  • Has a history of Torsades de Pointes or is taking medications known to prolong QT interval. To determine who will be excluded from this study based on this criterion, we will review participant's medical history and current medications at time of screening. Participants will be excluded from the study if any of the following restricted medications are being taken:
  • Disopyramide
  • Dofetilide
  • Ibutilide
  • Procainamide
  • Quinidine
  • Sotalol
  • Bepridil
  • Has hypersensitivity to F 18 T807 or any of its excipients.
  • Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
  • Severe claustrophobia.
  • Currently pregnant or breast-feeding.
  • For those electing to undergo the optional lumbar puncture: on
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesCognitive DysfunctionTauopathiesNeurodegenerative Diseases

Interventions

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

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Tammie Benzinger, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Radiology and Neurological Surgery

Study Record Dates

First Submitted

April 7, 2015

First Posted

March 14, 2016

Study Start

September 30, 2017

Primary Completion

September 30, 2020

Study Completion

December 30, 2020

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations

US(1)