Trial Outcomes & Findings for Florbetapir Calibration to the Centiloid Scale (NCT NCT02120664)

Results Overview

Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (\<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

up to 70 minutes post injection

Results posted on

2017-03-09

Participant Flow

First subject enrolled: 14 April 2014; Last subject completed: 18 September 2015

Participant milestones

Participant milestones
Measure	Clincally Diagnosed AD Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)	Possible AD Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease	Mild Cognitive Impairment (MCI) Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater	At Risk Elderly Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal	Young Healthy Controls (YHC) Cognitively normal young subjects between 21 and 45 years of age (inclusive)
Overall Study STARTED	10	4	7	4	10
Overall Study COMPLETED	10	4	7	3	10
Overall Study NOT COMPLETED	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Clincally Diagnosed AD Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)	Possible AD Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease	Mild Cognitive Impairment (MCI) Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater	At Risk Elderly Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal	Young Healthy Controls (YHC) Cognitively normal young subjects between 21 and 45 years of age (inclusive)
Overall Study Withdrawal by Subject	0	0	0	1	0

Baseline Characteristics

Florbetapir Calibration to the Centiloid Scale

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clincally Diagnosed AD n=10 Participants Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)	Possible AD n=4 Participants Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease	Mild Cognitive Impairment (MCI) n=7 Participants Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater	At Risk Elderly n=4 Participants Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal	Young Healthy Controls (YHC) n=10 Participants Cognitively normal young subjects between 21 and 45 years of age (inclusive)	Total n=35 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 4.94 • n=5 Participants	66 years STANDARD_DEVIATION 4.76 • n=7 Participants	79.9 years STANDARD_DEVIATION 8.47 • n=5 Participants	79.3 years STANDARD_DEVIATION 2.5 • n=4 Participants	27.3 years STANDARD_DEVIATION 4.83 • n=21 Participants	60.1 years STANDARD_DEVIATION 22.28 • n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants	15 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	20 Participants n=8 Participants
Mini Mental Status Exam	23.7 units on a scale STANDARD_DEVIATION 2.45 • n=5 Participants	21.8 units on a scale STANDARD_DEVIATION 4.92 • n=7 Participants	26.4 units on a scale STANDARD_DEVIATION 1.27 • n=5 Participants	29.3 units on a scale STANDARD_DEVIATION 0.96 • n=4 Participants	29.5 units on a scale STANDARD_DEVIATION 0.53 • n=21 Participants	26.3 units on a scale STANDARD_DEVIATION 3.55 • n=8 Participants

PRIMARY outcome

Timeframe: up to 70 minutes post injection

Population: All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete a florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan.

Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (\<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.

Outcome measures

Outcome measures
Measure	Clincally Diagnosed AD n=10 Participants Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)	Possible AD n=3 Participants Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease	Mild Cognitive Impairment (MCI) n=7 Participants Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater	At Risk Elderly n=3 Participants Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal	Young Healthy Controls (YHC) n=10 Participants Cognitively normal young subjects between 21 and 45 years of age (inclusive)
Florbetapir SUVr Conversion to Centiloid Units	82.44 centiloid Standard Deviation 45.623	50.75 centiloid Standard Deviation 60.383	81.19 centiloid Standard Deviation 66.357	14.93 centiloid Standard Deviation 35.885	5.24 centiloid Standard Deviation 11.981

SECONDARY outcome

Timeframe: up to 70 minutes post injection

Population: All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete the florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan.

Correlation coefficient between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (\<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.

Outcome measures

Outcome measures
Measure	Clincally Diagnosed AD n=10 Participants Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)	Possible AD n=3 Participants Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease	Mild Cognitive Impairment (MCI) n=7 Participants Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater	At Risk Elderly n=3 Participants Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal	Young Healthy Controls (YHC) n=10 Participants Cognitively normal young subjects between 21 and 45 years of age (inclusive)
Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid Florbetapir	82.44 centiloid Standard Deviation 45.623	50.75 centiloid Standard Deviation 60.383	81.19 centiloid Standard Deviation 66.357	14.93 centiloid Standard Deviation 35.885	5.24 centiloid Standard Deviation 11.981
Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid 11C-PiB	87.18 centiloid Standard Deviation 41.105	54.52 centiloid Standard Deviation 56.511	74.33 centiloid Standard Deviation 57.597	26.39 centiloid Standard Deviation 37.464	0.73 centiloid Standard Deviation 2.414

SECONDARY outcome

Timeframe: up to 70 minutes post injection

Population: Young healthy controls enrolled in the study

Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure.

Outcome measures

Outcome measures
Measure	Clincally Diagnosed AD n=10 Participants Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)	Possible AD n=10 Participants Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease	Mild Cognitive Impairment (MCI) Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater	At Risk Elderly Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal	Young Healthy Controls (YHC) Cognitively normal young subjects between 21 and 45 years of age (inclusive)
Variability of PET Images in Young Healthy Control Subjects.	1.01 SUVr Standard Deviation 0.026	0.98 SUVr Standard Deviation 0.066	—	—	—

Adverse Events

Florbetapir Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PiB Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Both

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Total

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Avid Radiopharmaceuticals, Inc.

Phone: 215-298-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60