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

NCT01723488 | Terminated Early Phase 1

• 1 other identifier: T808000
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Alzheimers Disease

Keywords

AD

Outcome Measures

Primary Outcomes (1)

• To monitor and assess the safety of IV administration of [F-18]T808

  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 Outcomes (1)

• To begin collection of baseline [F-18]T808 PET/CT imaging data

  up to14 days per patient

Study Arms (1)

Tau diagnostic

EXPERIMENTAL

Experimental: Tau diagnostic \[F18\] T808

Radiation: [F18] T808

Interventions

[F18] T808 RADIATION

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

Also known as: Tau [F-18]T808

Tau diagnostic

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (2)

Research Site

Irvine, California, 92697, United States

Location

Research Site

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

tau Proteins

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Microtubule-Associated Proteins; Microtubule Proteins; Cytoskeletal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 8, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 19, 2013

Record last verified: 2013-07

Locations

US (2)