Imaging Characteristics of a Follow-up 18F-AV-1451 Scan | NCT02051764

Imaging Characteristics of a Follow-up 18F-AV-1451 Scan | NCT02051764 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Follow-up Flortaucipir PET Scan	Experimental		Drug: Flortaucipir F18 Drug: Florbetapir F 18 Procedure: Brain PET Scan

Name	Type	Description	Arm Group Labels	Other Names
Flortaucipir F18	Drug	370 megabecquerel (MBq) IV single-dose	Follow-up Flortaucipir PET Scan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Tau Deposition	Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.	baseline scan and at least 6 months after baseline scan

Contacts/Locations Module

Name	Affiliation	Role
Chief Medical Officer	Avid Radiopharmaceuticals, Inc.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Hoag Memorial Hospital		Newport Beach	California	92663	United States
UC Irvine Medical Center

Arm/Group Information

ID	Title	Description
FG000	Cognitively Impaired	Clinically-diagnosed Alzheimer's disease (AD), mild cognitive impairment (MCI), and other dementing disorders (ODD) from the flortaucipir PET scan arm
FG001	Healthy Volunteers	Male or female subjects ≥50 years of age without cognitive impairment from the flortaucipir PET scan arm

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00016 subjects FG00128 subjects
COMPLETED		FG00016 subjects FG00121 subjects
NOT COMPLETED		FG0000 subjects FG0017 subjects

Type	Comment	Reasons
Study terminated by sponsor		FG0000 subjects FG0017 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Cognitively Impaired	Clinically-diagnosed AD, MCI, and other dementing disorders (ODD) from the flortaucipir PET scan arm
BG001	Healthy Volunteers	Healthy Volunteers from the flortaucipir PET scan arm

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Tau Deposition

Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Amyloid positive and negative row n's reflect the subgroup counts.

Posted

Mean

Standard Deviation

standardized uptake value ratio (SUVr)

baseline scan and at least 6 months after baseline scan

ID	Title	Description
OG000	Cognitively Impaired	Clinically-diagnosed AD, MCI, and other dementing disorders (ODD) from the flortaucipir PET scan arm
OG001	Healthy Volunteers

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cognitively Impaired	Clinically-diagnosed Alzheimer's disease (AD), mild cognitive impairment (MCI), and other dementing disorders (ODD) from the flortaucipir PET scan arm

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Headache	Nervous system disorders	MedDRA (17.0)	Non-systematic Assessment	Moderate

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Medical Director	Avid Radiopharmaceuticals, Inc.	215-298-0700		clinicaloperations@avidrp.com

Condition Browse Module

ID	Term
D000544	Alzheimer Disease

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
C545186	florbetapir

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG0020
Not Hispanic or Latino	BG00016 BG00121 BG00237
Unknown or Not Reported	BG0000 BG0010 BG0020

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG0021
Asian	BG0000 BG0010 BG0020
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0000 BG0011 BG0021
White	BG00016 BG00119 BG00235
More than one race	BG0000 BG0010 BG0020
Unknown or Not Reported	BG0000 BG0010 BG0020

Amyloid status

Amyloid status as previously determined either by PET imaging or cerebral spinal fluid (CSF) measures

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Positive	BG00014 BG00116 BG00230
Negative	BG0002 BG0015 BG0027

Title

Denominators

Categories

Overall

- ParticipantsOG00016
- ParticipantsOG00121

Title	Measurements
	OG0000.0347± 0.047 OG001-0.0008± 0.013

Amyloid Negative

- ParticipantsOG0002
- ParticipantsOG0015

Title	Measurements
	OG0000.0364± 0.082 OG001

Amyloid Positive

- ParticipantsOG00014
- ParticipantsOG00116

Title	Measurements
	OG0000.0345± 0.045 OG001

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Overall change from baseline between groups. Test compared slopes of cognitively impaired (CI) vs healthy volunteers (HV). As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were the different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.	ANCOVA	Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.	0.2837	Not adjusted for multiple comparisons. No a priori threshold was selected.	Other
OG000 OG001	Change from baseline between groups for amyloid negative only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.	ANCOVA	Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.	0.9276	Not adjusted for multiple comparisons. No a priori threshold was selected.	Other
OG000 OG001	Change from baseline between groups for amyloid positive only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.	ANCOVA	Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.	0.6324	Not adjusted for multiple comparisons. No a priori threshold was selected.	Other