A Phase 0, Open Label, Multi-Center, Exploratory and Safety Study of [F-18]T808 (T808)

July 18, 2013 updated by: Avid Radiopharmaceuticals

A Phase 0, Open Label, Non-Randomized, Multi-Center, Exploratory and Safety Study of [F-18]T808

[F-18]T808 is being developed as a diagnostic radiopharmaceutical for PET imaging of the human brain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Siemens Molecular Imaging (SMI) is seeking to determine if [F-18]T808 might be useful as a non-invasive assessment tool in the clinical evaluation of subjects with conditions associated with tau protein aggregates, such as Alzheimer's disease. The information collected under this exploratory study will not be used for diagnostic purposes, assessments of the participant's response to therapy or for clinical management of the participants. However, this exploratory study will provide baseline information on the safety, biodistribution, and dosimetry of [F-18]T808. These data will aid in the design of future studies of [F-18]T808 in patients with Alzheimer's disease. Overall, this study will provide initial data that inform the development of [F-18]T808 as the first PET imaging agent for human tau protein related pathology.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • Research Site
      • Los Angeles, California, United States, 90033
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Low Probability for AD Participants (Group 1)

  • Participant is of any race/gender/ethnicity who has reached his or her 55th birthday at the time of informed consent.
  • Participant provides written informed consent Participant is capable of complying with study procedures
  • Participant is capable of communicating with study personnel
  • Participant understands and speaks English
  • Participant has at least an 8th Grade education
  • In the Investigator"s opinion, participant has a low probability of being currently positive for AD as determined by a Mini Mental State Examination (MMSE ≥ 28) defined in APPENDIX VI of XXX protocol
  • Participant has no significant hepatic or renal disease as defined by previous medical history and lab results are within the following ranges: Total bilirubin within 2x institutional upper limits of normal AST (SGOT) ≤ 2.5 x institutional upper limits of normal ALT (SGPT) ≤ 2.5 x institutional upper limits of normal Creatinine ≤ 2x institutional upper limits of normal BUN within 2x institutional upper limits of normal

High Probability for AD Participants (Group 2)

  • Participant is of any race/gender/ethnicity who has reached his or her 55th birthday at the time of informed consent.
  • Participant or participant"s legally acceptable representative provides written informed consent Participant is capable of complying with study procedures
  • Participant is capable of communicating with study personnel
  • Participant understands and speaks English
  • Participant has at least an 8th Grade education In the Investigator"s opinion, *participant has a high probability of being currently positive for AD that is determined by a Mini Mental State Examination (MMSE < 17) defined in APPENDIX VI of XXX protocol
  • Participant has no significant hepatic or renal disease as defined by previous medical history, and lab results are within the following ranges: Total bilirubin within 2x institutional upper limits of normal AST (SGOT) ≤ 2.5 x institutional upper limits of normal ALT (SGPT) ≤ 2.5 x institutional upper limits of normal Creatinine ≤ 2x institutional upper limits of normal BUN within 2x institutional upper limits of normal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tau diagnostic
Experimental: Tau diagnostic [F18] T808
Radiation: [F18] T808
Dose for normal volunteer undergoing dosimetry evaluation will not exceed 20 mCi, dose for high probability of Alzheimer's and low probability Alzheimer's undergoing brain imaging only will not exceed 10 mCi
Other Names:
  • Tau [F-18]T808

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To monitor and assess the safety of IV administration of [F-18]T808
Time Frame: up to15 days per patient.
To monitor and assess the safety of IV administration of [F-18]T808 To evaluate the bio-distribution and radiation dosimetry of [F-18]T808 in participants with low probability of Alzheimer"s disease (AD) using PET/CT whole body imaging To evaluate the metabolism of [F-18]T808 in participants with low probability of AD using serial blood samples collected pre- and post-IP administration To evaluate [F-18]T808 uptake and signal/background information in brain PET/CT imaging of participants with a high probability of currently being positive for AD and age-matched participants with a low probability of currently being positive for AD
up to15 days per patient.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To begin collection of baseline [F-18]T808 PET/CT imaging data
Time Frame: up to14 days per patient
To begin collection of baseline [F-18]T808 PET/CT imaging data To gain information to improve the study design for the conduct of future trials
up to14 days per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avid Radiopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 1, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (Estimate)

November 8, 2012

Study Record Updates

Last Update Posted (Estimate)

July 19, 2013

Last Update Submitted That Met QC Criteria

July 18, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T808000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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