Florbetapir Calibration to the Centiloid Scale

Study Overview
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Brief Summary
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This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.

Official Title
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A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Florbetapir (18F)
* Drug: 11C-PiB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cognitively Normal Subjects Males or females ≥ 21 and ≤ 45 years of age Mini-mental state examination (MMSE) ≥ 29 Clinically Diagnosed AD Subject Males or females ≥ 50 years of age Meet clinical criteria for dementia due to probable AD MMSE ≥ 16 and ≤ 26 Possible AD Subject Males or females ≥ 50 years of age Meet clinical criteria for dementia due to possible AD MMSE ≥ 16 and ≤ 26 MCI Subject Males or females ≥ 60 years of age with cognitive impairment (not dementia) MMSE >24 and <29 At Risk Elderly Subject Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years of age MMSE ≥ 27 Exclusion Criteria: Have had or currently have a diagnosis of neurodegenerative disorders other than AD Have a current serious or unstable illness that could interfere with completion of the study Subject has a known brain lesion, pathology or traumatic brain injury Have received or participated in a trial with investigational medications in the past 30 days Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amyloid Negative Subjects<br>Approximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie [mCi]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB. | Drug: Florbetapir (18F)<br> <br> * Other names: 18F-AV-45;Drug: 11C-PiB<br> <br> * Other names: Pittsburgh Compound B;|
| Experimental: Amyloid Positive Subjects<br>Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB. | Drug: Florbetapir (18F)<br> <br> * Other names: 18F-AV-45;Drug: 11C-PiB<br> <br> * Other names: Pittsburgh Compound B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Florbetapir SUVr Conversion to Centiloid Units | 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. | up to 70 minutes post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid | 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. | up to 70 minutes post injection | 
| Variability of PET Images in Young Healthy Control Subjects. | Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure. | up to 70 minutes post injection |