A Phase 0, Open Label, Multi-Center, Exploratory and Safety Study of [F-18]T808
NCT ID: NCT01723488
Last Updated: 2013-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
12 participants
INTERVENTIONAL
2012-07-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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Tau diagnostic
Experimental: Tau diagnostic \[F18\] T808
[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
Interventions
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[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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
55 Years
ALL
Yes
Sponsors
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Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Avid Radiopharmaceuticals
Locations
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Research Site
Irvine, California, United States
Research Site
Los Angeles, California, United States
Countries
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Other Identifiers
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T808000
Identifier Type: -
Identifier Source: org_study_id
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