- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01733355
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
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
Interventional
Enrollment (Actual)
11
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
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California
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Irvine, California, United States, 92697
- Research Site
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Los Angeles, California, United States, 90033
- Research Site
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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
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 |
Intervention / Treatment |
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EXPERIMENTAL: Tau diagnostic
[F18] T807
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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:
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What is the study measuring?
Primary Outcome Measures
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
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up to 15 days per patient
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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
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up to 15 days per patient
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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
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upto 15 days per patient
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To assess the safety of IV administration of [F-18]T807
Time Frame: up to 24 hours post [F18]T807 administration
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Safety will be monitored for all subjects by the:
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up to 24 hours post [F18]T807 administration
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Secondary Outcome Measures
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
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up to 15 days per patient
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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
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up to 15 days per patient
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 25, 2012
First Submitted That Met QC Criteria
November 20, 2012
First Posted (ESTIMATE)
November 27, 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
Additional Relevant MeSH Terms
Other Study ID 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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