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A Phase 0, Open Label, Multi-Center, Exploratory and Safety Study of [F-18]T808 | Clinical Trials | Clareo Health

TERMINATEDEARLY_PHASE1

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

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

NCT01723488•Avid Radiopharmaceuticals

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

55 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion 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.
+5 more criteria

Locations (2)

Research Site

Irvine, California, United States

Research Site

Los Angeles, California, United States

Key Dates

Start Date

July 1, 2012

Primary Completion Date

March 1, 2013

Completion Date

March 1, 2013

Last Updated

July 19, 2013

Enrollment

ACTUAL participants

Conditions

Alzheimers Disease

Interventions

[F18] T808

RADIATION

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Alzheimers Disease

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RECRUITINGPHASE3

Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies

NCT07177352

Alzheimers Disease

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ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

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