A Phase 0, Open Label, Multi-center Exploratory and Safety Study of [F-18]T807

July 18, 2013 updated by: Avid Radiopharmaceuticals

A Phase 0, Open Label, Non-randomized, Multi-center Exploratory and Safety Study of [F-18]T807

[F-18]T807 is being developed as a diagnostic radiopharmaceutical for PET imaging of the human brain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Siemens Molecular Imaging (SMI) is seeking to determine if [F-18]T807 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]T807. These data will aid in the design of future studies of [F-18]T807 in patients with Alzheimer's disease. Overall, this study will provide initial data that inform the development of [F-18]T807 as the first PET imaging agent for human tau protein related pathology.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria; Low Probability for AD Participants (Group 1)

  • Participant has reached his or her 55th birthday at the time of informed consent (Participant is male or female of any race / ethnicity)
  • 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 protocol T807000, IND 114102
  • 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 has reached his or her 55th birthday at the time of informed consent (Participant is male or female of any race / ethnicity)
  • 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 protocol T807000, IND 114102.
  • 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

Exclusion Criteria; All Participants

  • Female participant is pregnant or nursing
  • Participant has prior history of stroke or other condition of the head or neck that, in the Investigator's opinion, might affect circulation to the head or image interpretation
  • Participant has other neurodegenerative disease that is associated with cognitive impairment or dementia
  • Participant has a medical condition that might be associated with elevated amyloid levels, such as amyloid angiopathy, familial amyloidosis, chronic kidney dialysis, Down's syndrome
  • Participant has a history of significant cerebrovascular disease
  • Participant has previously received [F-18]T807 at any time
  • Participant has been involved in an investigative, radioactive research procedure within the past 14 days
  • Participant has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete data or data quality
  • Participant has a history in the last five years of significant prescription or non-prescription drug or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Tau diagnostic
[F18] T807
Radiation: [F18] T807
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]T807

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the bio-distribution and radiation dosimetry of [F-18]T807 in participants with low probability of Alzheimer's disease (AD) using PET/CT whole body imaging
Time Frame: up to 15 days per patient
up to 15 days per patient
To evaluate the metabolism of [F-18]T807 in participants with low probability of AD using serial blood samples collected pre- and post-IP administration
Time Frame: up to 15 days per patient
up to 15 days per patient
To evaluate [F-18]T807 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
Time Frame: upto 15 days per patient
upto 15 days per patient
To assess the safety of IV administration of [F-18]T807
Time Frame: up to 24 hours post [F18]T807 administration

Safety will be monitored for all subjects by the:

  • Number of subjects experiencing adverse events from baseline to 24 hours post-administration.
  • Number and type of adverse events.
  • Changes in clinical laboratory assessments (CBC and clinical chemistry)from baseline to 24 hours post administration.
  • Changes in physical examination from baseline to 24 hours post administration.
  • Changes in vital sign measurements (systolic blood pressure [mmHg]; diastolic blood pressure [mmHg], pulse rate [bpm] and body temperature) from baseline prior to [F-18]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration)and at 24 hours post administration.
  • Changes in ECG measurements, from baseline prior to [F-18]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration) and at 24 hours post administration.
up to 24 hours post [F18]T807 administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To begin collection of baseline [F-18]T807 PET/CT imaging data
Time Frame: up to 15 days per patient
The secondary endpoint of this investigational study is the collection of baseline whole body PET/CT images and PET/CT images of the brain, following administration of [F-18]T807
up to 15 days per patient
To gain information to improve the study design for the conduct of future trials
Time Frame: up to 15 days per patient
The secondary endpoint of this investigational study is the collection of baseline whole body PET/CT images and PET/CT images of the brain, following administration of [F-18]T807
up to 15 days per patient

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T807000

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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