A Phase 0, Open Label, Multi-center Exploratory and Safet... | NCT01733355

NCT01733355

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Description	Intervention Names
Tau diagnostic	Experimental	[F18] T807	Radiation: [F18] T807

Name	Type	Description	Arm Group Labels	Other Names
[F18] T807	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the bio-distribution and radiation dosimetry of [F-18]T807 in participants with low probability of Alzheimer's disease (AD) using PET/CT whole body imaging		up to 15 days per patient
To evaluate the metabolism of [F-18]T807 in participants with low probability of AD using serial blood samples collected pre- and post-IP administration		up to 15 days per patient
To evaluate [F-18]T807 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		upto 15 days per patient
To assess the safety of IV administration of [F-18]T807	Safety will be monitored for all subjects by the: Number of subjects experiencing adverse events from baseline to 24 hours post-administration. Number and type of adverse events. Changes in clinical laboratory assessments (CBC and clinical chemistry)from baseline to 24 hours post administration. Changes in physical examination from baseline to 24 hours post administration. Changes in vital sign measurements (systolic blood pressure [mmHg]; diastolic blood pressure [mmHg], pulse rate [bpm] and body temperature) from baseline prior to [F-18]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration)and at 24 hours post administration. Changes in ECG measurements, from baseline prior to [F-18]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration) and at 24 hours post administration.	up to 24 hours post [F18]T807 administration

Secondary Outcomes

Measure	Description	Time Frame
To begin collection of baseline [F-18]T807 PET/CT imaging data	The secondary endpoint of this investigational study is the collection of baseline whole body PET/CT images and PET/CT images of the brain, following administration of [F-18]T807	up to 15 days per patient
To gain information to improve the study design for the conduct of future trials

Eligibility Module

Eligibility Criteria

Inclusion Criteria; Low Probability for AD Participants (Group 1)

Participant has reached his or her 55th birthday at the time of informed consent (Participant is male or female of any race / ethnicity)
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 protocol T807000, IND 114102
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 has reached his or her 55th birthday at the time of informed consent (Participant is male or female of any race / ethnicity)
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 protocol T807000, IND 114102.
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

Exclusion Criteria; All Participants

Female participant is pregnant or nursing
Participant has prior history of stroke or other condition of the head or neck that, in the Investigator's opinion, might affect circulation to the head or image interpretation
Participant has other neurodegenerative disease that is associated with cognitive impairment or dementia
Participant has a medical condition that might be associated with elevated amyloid levels, such as amyloid angiopathy, familial amyloidosis, chronic kidney dialysis, Down's syndrome
Participant has a history of significant cerebrovascular disease
Participant has previously received [F-18]T807 at any time
Participant has been involved in an investigative, radioactive research procedure within the past 14 days
Participant has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete data or data quality
Participant has a history in the last five years of significant prescription or non-prescription drug or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Irvine	California	92697	United States
Research Site

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
C000591008	7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole
D016875	tau Proteins

ID	Term
D008869	Microtubule-Associated Proteins
D008868	Microtubule Proteins
D003598	Cytoskeletal Proteins
D011506	Proteins