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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01723488
Recruitment Status : Terminated (Study was terminated in anticipation of transfer of ownership to Avid Radiopharmaceuticals.)
First Posted : November 8, 2012
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

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

Condition or disease Intervention/treatment Phase
Alzheimers Disease Radiation: [F18] T808 Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase 0, Open Label, Non-Randomized, Multi-Center, Exploratory and Safety Study of [F-18]T808
Study Start Date : July 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


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 Name: Tau [F-18]T808




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723488


Locations
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United States, California
Research Site
Irvine, California, United States, 92697
Research Site
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Director: Chief Medical Officer Avid Radiopharmaceuticals

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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01723488    
Other Study ID Numbers: T808000
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: July 2013
Keywords provided by Avid Radiopharmaceuticals:
AD
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders