Alzheimer Disease, Amyloid Beta-Protein
Conditions
Keywords
Alzheimer Disease, Amyloid beta-Protein
Brief summary
The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK 6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is therefore a potential tracer to be used for detecting amyloid plaques. For each subject it is required to visit the study centre during the screening phase, on the PET imaging day and for 1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7 days after IMP administration. During the screening phase the subject's medical, neurological and surgical history, specific laboratory tests related to AD, MRI of the brain and certain neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations, vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET imaging day before IMP injection and monitored during and after two PET imaging sessions. Clinical safety measures will be performed again on the follow-up visit next day. The results of PET imaging with IMP will be compared between probable AD patients and healthy volunteers (HV). The clinical diagnosis is based on international validated and accepted criteria and established after comprehensive clinical and neuro-psychiatric examinations
Interventions
Healthy volunteers and patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
Sponsors
Life Molecular Imaging SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Each subject / Healthy volunteer (HV) who meets the following criteria will be eligible for enrollment into the study: * Is a man or woman and is \> 55 of age, whereby females must be without childbearing potential (confirmed by either: age \>/= 60; or history of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start) * Has at least 6 years of education * Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and to comply with study procedures * Possesses a general health that permits adequate compliance with all study procedures * The subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study * Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients) * Inclusion criteria for HV only: * Has no evidence of cognitive impairment * Has MRI brain scan that has been judged as normal (age- appropriate) * Inclusion criteria for patients with AD only: * Presents with positive assessment for dementia of Alzheimer's type * Does not fulfill the criteria Dementia with Lewy Bodies (DLB) or Vascular Dementia (VaD) * MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease * Has a caregiver that is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
Exclusion criteria
* Has any contraindication to MRI examination scan * Is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application * Is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma) * is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable * Has a history of exposure to any radiation \>15 milli Sieverts (mSv)/year (e.g. occupational or radiation therapy) * Is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy) * Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical * Has a brain tumor or other intracranial lesion, a disturbance of cerebro-spinal fluid (CSF) circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery * Has an inflammatory or infectious central nervous system (CNS) disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeldt-Jacob disease * Has a history, physical, laboratory or imaging findings indicative of a neurological or psychiatric illness * Has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function) * Has a history of alcohol or drug abuse * Has history of severe persistent depression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth | 90 - 110 min after investigational medical product (IMP) injection | Part A: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan which was considered a match for specificity. Standard of truth was the onsite clinical diagnosis. Two Beta-Amyloid Plaque Load (BAPL) algorithms for assessing the normality/abnormality of beta-amyloid plaque load in the brain scans were used. Using algorithm A (Majority Read), a brain scan of a subject with a BAPL score of 1 (without beta-amyloid plaque load) or 2 (with minor beta-amyloid plaque load) was considered normal and a BAPL score of 3 (with significant beta-amyloid plaque load) was considered abnormal. Using algorithm B (Average), a brain scan of a subject with a BAPL score of 1 was considered normal and a brain scan with a BAPL score of 2 or 3 was considered abnormal. Algorithm B was used in Part B and in the final |
| Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth. | 90 - 110 min after IMP injection | Part B: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan, ie,abnormal scan (BAPL scores 2 or 3) which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan, ie,normal scan (BAPL score 1) which was considered a match for specificity. The clinical diagnosis was established by an independent consensus panel (CP) of experts in dementia. Two independent sets of PET data reads were performed. The first set was performed by a panel of three readers who received live, instructor-led training on the visual assessment procedure. The second set was performed by a panel of five separate readers who were trained on the visual assessment procedure with electronic media. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment | 45 - 60 min and 110 - 130 min after IMP injection | PET scans from two additional imaging windows (45-60 min and 110-130 min) were visually assessed |
| Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score) | 45-60 min, 90-110 min, 110-130 min | The agreement between 3 blinded readers concerning the visual assessment of abnormality of the brain scan (based on BAPL score) was measured by the kappa coefficient. Kappa values close to 1.0 indicate a high agreement while values close to 0 indicate random agreement. |
| Standard Uptake Value Ratios for Florbetaben Signal | 90-110 min post injection | The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, lateral temporal cortex, parietal cortex, anterior cingulate, posterior cingulate cortex, occipital cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.) |
Countries
Australia, Germany, Japan, Switzerland, United States
Participant flow
Recruitment details
There were two parts in this study, Part A and Part B. Part A was conducted in Australia, Germany, Switzerland and USA. Subjects were recruited from 17 centers. HVs were age matched to subjects with probable Alzheimer's (AD). Part B was conducted in Australia, Germany, Japan, Switzerland, and USA, subjects recruited from 22 centers.
Pre-assignment details
Part A screened 214 subjects; 113 AD and 101 HV. There were 63 screen failures (40 for inclusion criteria, 14 withdrew consent, 9 for other reasons) and one dropout prior to receiving study drug. Part B screened 392 subjects; 204 AD and 188 HV. There were 118 screen failures for similar reasons and 2 dropouts prior to receiving study drug.
Participants by arm
| Arm | Count |
|---|---|
| Part A Healthy Volunteers Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions | 69 |
| Part A Alzheimer Patients Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions | 81 |
| Part B Healthy Volunteers Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions | 125 |
| Part B Alzheimer Patients Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions | 147 |
| Total | 422 |
Baseline characteristics
| Characteristic | Part A Alzheimer Patients | Part B Healthy Volunteers | Part B Alzheimer Patients | Total | Part A Healthy Volunteers |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 62 Participants | 104 Participants | 132 Participants | 344 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 21 Participants | 15 Participants | 78 Participants | 23 Participants |
| Age, Continuous | 70.7 years STANDARD_DEVIATION 7.82 | 70.7 years STANDARD_DEVIATION 6.3 | 73.9 years STANDARD_DEVIATION 7.3 | 71.4 years STANDARD_DEVIATION 7.36 | 68.2 years STANDARD_DEVIATION 6.86 |
| Region of Enrollment Australia | 6 participants | 11 participants | 5 participants | 31 participants | 9 participants |
| Region of Enrollment Germany | 71 participants | 63 participants | 72 participants | 255 participants | 49 participants |
| Region of Enrollment Japan | 0 participants | 29 participants | 28 participants | 57 participants | 0 participants |
| Region of Enrollment Switzerland | 1 participants | 0 participants | 11 participants | 15 participants | 3 participants |
| Region of Enrollment United States | 3 participants | 22 participants | 31 participants | 64 participants | 8 participants |
| Sex: Female, Male Female | 36 Participants | 52 Participants | 73 Participants | 200 Participants | 39 Participants |
| Sex: Female, Male Male | 45 Participants | 73 Participants | 74 Participants | 222 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 69 | 3 / 81 | 17 / 125 | 23 / 147 |
| serious Total, serious adverse events | 1 / 69 | 1 / 81 | 2 / 125 | 0 / 147 |
Outcome results
Primary
Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth
Part A: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan which was considered a match for specificity. Standard of truth was the onsite clinical diagnosis. Two Beta-Amyloid Plaque Load (BAPL) algorithms for assessing the normality/abnormality of beta-amyloid plaque load in the brain scans were used. Using algorithm A (Majority Read), a brain scan of a subject with a BAPL score of 1 (without beta-amyloid plaque load) or 2 (with minor beta-amyloid plaque load) was considered normal and a BAPL score of 3 (with significant beta-amyloid plaque load) was considered abnormal. Using algorithm B (Average), a brain scan of a subject with a BAPL score of 1 was considered normal and a brain scan with a BAPL score of 2 or 3 was considered abnormal. Algorithm B was used in Part B and in the final
Time frame: 90 - 110 min after investigational medical product (IMP) injection
Population: All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis.(n=146)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AD (Sensitivity) Group | Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth | Majority Read Sens/ Spec (BAPL2 = abnormal) | 79.49 percentage of subjects |
| AD (Sensitivity) Group | Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth | Average Sens / Spec (BAPL2 = normal) | 74.79 percentage of subjects |
| HV (Specificity) Group | Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth | Majority Read Sens/ Spec (BAPL2 = abnormal) | 91.18 percentage of subjects |
| HV (Specificity) Group | Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth | Average Sens / Spec (BAPL2 = normal) | 96.08 percentage of subjects |
Primary
Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth.
Part B: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan, ie,abnormal scan (BAPL scores 2 or 3) which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan, ie,normal scan (BAPL score 1) which was considered a match for specificity. The clinical diagnosis was established by an independent consensus panel (CP) of experts in dementia. Two independent sets of PET data reads were performed. The first set was performed by a panel of three readers who received live, instructor-led training on the visual assessment procedure. The second set was performed by a panel of five separate readers who were trained on the visual assessment procedure with electronic media.
Time frame: 90 - 110 min after IMP injection
Population: All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AD (Sensitivity) Group | Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth. | Sens / Spec (average 3 readers) | 67.24 percentage of subjects |
| AD (Sensitivity) Group | Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth. | Sens / Spec (additional read, median 5 readers) | 78.5 percentage of subjects |
| HV (Specificity) Group | Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth. | Sens / Spec (average 3 readers) | 96.61 percentage of subjects |
| HV (Specificity) Group | Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth. | Sens / Spec (additional read, median 5 readers) | 89.2 percentage of subjects |
Secondary
Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score)
The agreement between 3 blinded readers concerning the visual assessment of abnormality of the brain scan (based on BAPL score) was measured by the kappa coefficient. Kappa values close to 1.0 indicate a high agreement while values close to 0 indicate random agreement.
Time frame: 45-60 min, 90-110 min, 110-130 min
Population: All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AD (Sensitivity) Group | Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score) | 0.56 Kappa coefficient |
| HV (Specificity) Group | Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score) | 0.60 Kappa coefficient |
| AD (Sensitivity) Group (Part B) | Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score) | 0.67 Kappa coefficient |
| HV (Specificity) Group (Part B) | Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score) | 0.78 Kappa coefficient |
| Imaging Window 90-110 Min Part B | Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score) | 0.86 Kappa coefficient |
| Imaging Window 110-130 Min Part B | Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score) | 0.86 Kappa coefficient |
Secondary
Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment
PET scans from two additional imaging windows (45-60 min and 110-130 min) were visually assessed
Time frame: 45 - 60 min and 110 - 130 min after IMP injection
Population: All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AD (Sensitivity) Group | Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment | Sensitivity & Specificity (110-130 min) | 70.56 percentage of subjects |
| AD (Sensitivity) Group | Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment | Sensitivity & Specificity (45-60 min) | 73.93 percentage of subjects |
| HV (Specificity) Group | Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment | Sensitivity & Specificity (45-60 min) | 94.61 percentage of subjects |
| HV (Specificity) Group | Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment | Sensitivity & Specificity (110-130 min) | 98.01 percentage of subjects |
| AD (Sensitivity) Group (Part B) | Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment | Sensitivity & Specificity (110-130 min) | 73.04 percentage of subjects |
| AD (Sensitivity) Group (Part B) | Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment | Sensitivity & Specificity (45-60 min) | 71.55 percentage of subjects |
| HV (Specificity) Group (Part B) | Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment | Sensitivity & Specificity (110-130 min) | 96.58 percentage of subjects |
| HV (Specificity) Group (Part B) | Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment | Sensitivity & Specificity (45-60 min) | 94.07 percentage of subjects |
Secondary
Standard Uptake Value Ratios for Florbetaben Signal
The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, lateral temporal cortex, parietal cortex, anterior cingulate, posterior cingulate cortex, occipital cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.)
Time frame: 90-110 min post injection
Population: All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AD (Sensitivity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Frontal cortex | 1.608 ratio | Standard Deviation 0.3207 |
| AD (Sensitivity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Anterior cingulate | 1.723 ratio | Standard Deviation 0.3522 |
| AD (Sensitivity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Parietal cortex | 1.528 ratio | Standard Deviation 0.2896 |
| AD (Sensitivity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Composite SUVR | 1.620 ratio | Standard Deviation 0.29 |
| AD (Sensitivity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Occipital cortex | 1.495 ratio | Standard Deviation 0.2203 |
| AD (Sensitivity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Posterior cingulate cortex | 1.795 ratio | Standard Deviation 0.3149 |
| AD (Sensitivity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Lateral temporal cortex | 1.571 ratio | Standard Deviation 0.2881 |
| HV (Specificity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Posterior cingulate cortex | 1.422 ratio | Standard Deviation 0.1565 |
| HV (Specificity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Frontal cortex | 1.295 ratio | Standard Deviation 0.1151 |
| HV (Specificity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Lateral temporal cortex | 1.259 ratio | Standard Deviation 0.1058 |
| HV (Specificity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Parietal cortex | 1.234 ratio | Standard Deviation 0.1161 |
| HV (Specificity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Anterior cingulate | 1.397 ratio | Standard Deviation 0.1425 |
| HV (Specificity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Occipital cortex | 1.309 ratio | Standard Deviation 0.0864 |
| HV (Specificity) Group | Standard Uptake Value Ratios for Florbetaben Signal | Composite SUVR | 1.320 ratio | Standard Deviation 0.11 |
| AD (Sensitivity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Lateral temporal cortex | 1.619 ratio | Standard Deviation 0.2787 |
| AD (Sensitivity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Anterior cingulate | 1.786 ratio | Standard Deviation 0.3145 |
| AD (Sensitivity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Posterior cingulate cortex | 1.852 ratio | Standard Deviation 0.3187 |
| AD (Sensitivity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Frontal cortex | 1.646 ratio | Standard Deviation 0.2905 |
| AD (Sensitivity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Composite SUVR | 1.678 ratio | Standard Deviation 0.2699 |
| AD (Sensitivity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Occipital cortex | 1.560 ratio | Standard Deviation 0.246 |
| AD (Sensitivity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Parietal cortex | 1.602 ratio | Standard Deviation 0.2705 |
| HV (Specificity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Parietal cortex | 1.267 ratio | Standard Deviation 0.1709 |
| HV (Specificity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Composite SUVR | 1.355 ratio | Standard Deviation 0.1784 |
| HV (Specificity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Anterior cingulate | 1.434 ratio | Standard Deviation 0.2387 |
| HV (Specificity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Frontal cortex | 1.301 ratio | Standard Deviation 0.1961 |
| HV (Specificity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Occipital cortex | 1.341 ratio | Standard Deviation 0.1281 |
| HV (Specificity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Posterior cingulate cortex | 1.493 ratio | Standard Deviation 0.2351 |
| HV (Specificity) Group (Part B) | Standard Uptake Value Ratios for Florbetaben Signal | Lateral temporal cortex | 1.292 ratio | Standard Deviation 0.162 |