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

Alzheimers Disease Clinical Trial

— T808  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01723488
• Other study ID #: T808000
• Status: Terminated
• Phase: Phase 0
• First received: November 1, 2012
• Last updated: July 18, 2013
• Start date: July 2012
• Est. completion date: March 2013

Study information

• Verified date: July 2013
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimers Disease

Intervention

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

Locations

Country	Name	City	State
United States	Research Site	Irvine	California
United States	Research Site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	To begin collection of baseline [F-18]T808 PET/CT imaging data	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	up to14 days per patient	Yes