Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)

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ClinicalTrials.gov Identifier: NCT01607476

Recruitment Status : Completed

First Posted : May 30, 2012

Results First Posted : November 1, 2016

Last Update Posted : April 18, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Val Lowe, Mayo Clinic

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
Condition	Alzheimer's Disease
Interventions	Drug: C11 PiB Drug: F18 Flutametamol
Enrollment	89

Participant Flow

Recruitment Details	Participants were recruited from Mayo Clinic in Minnesota.
Pre-assignment Details	89 subjects were consented, but 1 subject was a screen failure prior to assignment.


Arm/Group Title	Alzheimer's Disease	Cognitive Normal Elderly	Cognitive Normal Young
Arm/Group Description	Subjects who have the clinical diag...	Cognitive Normal subjects who are g...	Cognitively normal subjects who are...
Arm/Group Description	Subjects who have the clinical diagnosis of probable Alzheimer's disease (AD) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 Pittsburgh Compound B (PiB) PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 millicurie (mCi) C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.	Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.	Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
Period Title: Overall Study
Started	25	30	33
Completed	24	30	30
Not Completed	1	0	3
Reason Not Completed
Withdrawal by Subject	1	0	1
Lost to Follow-up	0	0	2

Baseline Characteristics

Arm/Group Title		Alzheimer's Disease	Cognitive Normal Elderly	Cognitive Normal Young	Total
Arm/Group Description		Subjects who have the clinical diag...	Cognitive Normal subjects who are g...	Cognitively normal subjects who are...	Total of all reporting groups
Arm/Group Description		Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.	Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.	Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.	Total of all reporting groups
Overall Number of Baseline Participants		25	30	33	88
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	25 participants	30 participants	33 participants	88 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	25 100.0%	30 100.0%	33 100.0%	88 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	25 participants	30 participants	33 participants	88 participants
	Female	12 48.0%	19 63.3%	18 54.5%	49 55.7%
	Male	13 52.0%	11 36.7%	15 45.5%	39 44.3%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	25 participants	30 participants	33 participants	88 participants
United States		25	30	33	86

Outcome Measures

1.Primary Outcome


Title	Global Distribution of C11 PiB in the Brain
Description	The imaging analysts use a global atlas of the brain to measure the up...
Description	The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts. The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel.
Time Frame	Approximately one hour after injection of positron emission tomography (PET) drug

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Alzheimer's Disease	Cognitive Normal Elderly	Cognitive Normal Young
Arm/Group Description:	Subjects who have the clinical diag...	Cognitive Normal subjects who are g...	Cognitively normal subjects who are...
Arm/Group Description:	Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.	Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.	Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
Overall Number of Participants Analyzed	24	30	30
Mean (Standard Deviation) Unit of Measure: standard uptake value ratio
	2.50 (0.53)	1.47 (0.28)	1.23 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alzheimer's Disease, Cognitive Normal Elderly
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Alzheimer's Disease, Cognitive Normal Young
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cognitive Normal Elderly, Cognitive Normal Young
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

2.Primary Outcome


Title	Global Distribution of F18 Flutemetamol in the Brain
Description	The imaging analysts use a global atlas of the brain to measure the up...
Description	The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts. The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel.
Time Frame	Approximately one hour after injection of positron emission tomography (PET) drug

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Alzheimer's Disease	Cognitive Normal Elderly	Cognitive Normal Young
Arm/Group Description:	Subjects who have the clinical diag...	Cognitive Normal subjects who are g...	Cognitively normal subjects who are...
Arm/Group Description:	Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.	Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.	Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
Overall Number of Participants Analyzed	24	30	30
Mean (Standard Deviation) Unit of Measure: standard uptake value ratio
	2.49 (0.49)	1.59 (0.26)	1.34 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alzheimer's Disease, Cognitive Normal Elderly
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Alzheimer's Disease, Cognitive Normal Young
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cognitive Normal Elderly, Cognitive Normal Young
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Alzheimer's Disease		Cognitive Normal Elderly		Cognitive Normal Young
Arm/Group Description	Subjects who have the clinical diag...		Cognitive Normal subjects who are g...		Cognitively normal subjects who are...
Arm/Group Description	Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.		Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.		Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
All-Cause Mortality
	Alzheimer's Disease		Cognitive Normal Elderly		Cognitive Normal Young
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	Alzheimer's Disease		Cognitive Normal Elderly		Cognitive Normal Young
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0.00%)		0/30 (0.00%)		0/30 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Alzheimer's Disease		Cognitive Normal Elderly		Cognitive Normal Young
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/24 (4.17%)		4/30 (13.33%)		2/30 (6.67%)
Cardiac disorders
Heart palpitations (moderate) ^† [1]	0/24 (0.00%)	0	1/30 (3.33%)	1	0/30 (0.00%)	0
Eye disorders
Decreased vision ^† [2]	0/24 (0.00%)	0	1/30 (3.33%)	1	1/30 (3.33%)	1
Gastrointestinal disorders
Hypoglycemia ^† [1]	0/24 (0.00%)	0	0/30 (0.00%)	0	1/30 (3.33%)	1
Metallic taste ^† [3]	0/24 (0.00%)	0	1/30 (3.33%)	1	0/30 (0.00%)	0
Musculoskeletal and connective tissue disorders
Leg cramp (mild) ^† [4]	0/24 (0.00%)	0	1/30 (3.33%)	1	0/30 (0.00%)	0
Nervous system disorders
Dizziness (mild) ^† [4]	1/24 (4.17%)	1	0/30 (0.00%)	0	0/30 (0.00%)	0
† Indicates events were collected by systematic assessment [1] Event experienced while subject on F-18 Flutemetamol, determined to be unrelated to study drug. [2] Event experienced while subjects were on C-11 PIB, determined to be unrelated to study drug [3] Event experienced while subject was on F-18 Flutemetamol, determined to be not related to study drug. [4] Event experienced while subject was on F-18 Flutemetamol, determined to be unrelated to study drug.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Val Lowe
Organization:	Mayo Clinic
Phone:	507-255-3616
EMail:	vlowe@mayo.edu

Layout table for additonal information

Responsible Party:	Val Lowe, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01607476
Other Study ID Numbers:	12-000118
First Submitted:	May 23, 2012
First Posted:	May 30, 2012
Results First Submitted:	August 2, 2016
Results First Posted:	November 1, 2016
Last Update Posted:	April 18, 2017

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