Alzheimer Disease, Amyloid Beta-Protein
Conditions
Keywords
Florbetaben, Amyloid beta-protein, MCI, Alzheimer's disease
Brief summary
The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.
Interventions
single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
Sponsors
Life Molecular Imaging SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of MCI defined as abnormal cognition on objective testing in the absence of dementia or significant functional loss. * Absence of systemic or other neurological disease that may contribute to cognitive impairment or prevent follow-up over two years. * Able to give written informed consent. * Age \>/= 60 years of age * \>/= 7 years of education
Exclusion criteria
* Mini mental state examination (MMSE) score \< 24 at baseline * Clinical dementia rating (CDR) score \> 0.5 at baseline * Patients who receive regular medication of drugs which may adversely impact cognition (e.g. tricyclic antidepressants, antipsychotics and/or large doses of hypnotics or anxiolytics) * Existing or history of cancer * History of severe head trauma, brain surgery or intracranial hematoma with permanent brain lesion * Lifetime history of major affective disorder, schizophrenia, or schizo-affective disorder * Contraindications to MRI (Magnetic resonance imaging) * Relevant history, physical or imaging findings of neurological disease other than MCI and mild depression * History of severe anaphylactic reaction or high risk of allergic reaction to drugs * Patient has received another investigational drug in the preceding 14 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake | 1 scanning period post injection to be evaluated at baseline, 12 months and 24 months | Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | 1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months | This outcome measure showed the number of abnormal scans in subjects with MCI progressing to AD and those who did not progress compared to subjects with normal scans that did not progress and those who did progress. |
| Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months | At each study time point (baseline, 12 months and 24 months) PET images were obtained at 45 min and again at 90 post injection. These images were assigned a BAPL score of 1, 2 or 3 based on the reader's evaluation of the scan. A BAPL scores of 1 was considered normal, and scores of 2 and 3 were considered abnormal. These scores were compared to subjects clinical diagnosis for AD at the end of the study follow up period. |
| Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | 2 scanning periods post injection to be evaluated at baseline | Sensitivity, specificity, NPV and PPV were measured based on subject BAPL scores by time point and imaging window, compared to clinical diagnosis of AD during the study period. A BAPL score of 1 was considered negative for the presence of beta-amyloid, and scores of 2 and 3 were considered positive. For this study, sensitivity was defined as the percentage of subjects with a clinical diagnosis of AD who also had a positive PET scan (BAPL score of 2 or 3) at the respective time point. Specificity was defined as the percentage of subjects with a clinical diagnosis of non-AD who also had a negative PET scan (BAPL score of 0 or 1) at the respective time point. PPV was defined as the probability that a subject with a positive PET scan would have a clinical diagnosis of AD sometime during the 2 year follow up period. NPV was defined as the probability that a subject with a negative PET scan would not have a clinical diagnosis of AD at any point during the 2 year follow up period. |
Countries
Australia
Participant flow
Recruitment details
A total of 71 patients were screened at one study center in Australia. The first subject's consent was obtained on 02 JUN 2008.
Pre-assignment details
26 subjects were screen failures and did not have study drug administered.
Participants by arm
| Arm | Count |
|---|---|
| MCI Subjects Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | MCI Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 39 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 72.7 years STANDARD_DEVIATION 6.5 |
| Region of Enrollment Australia | 45 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 45 | 3 / 41 | 2 / 36 |
| serious Total, serious adverse events | 0 / 45 | 0 / 41 | 2 / 36 |
Outcome results
Primary
Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months)
Time frame: 1 scanning period post injection to be evaluated at baseline, 12 months and 24 months
Population: All subjects receiving study drug with PET scan data at the respective timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Not Progressed to AD (Baseline) | Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake | 1.430 SUVR | Standard Deviation 0.252 |
| Progressed to AD (Baseline) | Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake | 1.726 SUVR | Standard Deviation 0.227 |
| Not Progressed to AD (12 Month) | Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake | 1.442 SUVR | Standard Deviation 0.27 |
| Progressed to AD (12 Month) | Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake | 1.738 SUVR | Standard Deviation 0.236 |
| Not Progressed to AD (24 Month) | Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake | 1.439 SUVR | Standard Deviation 0.219 |
| Progressed to AD (24 Month) | Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake | 1.796 SUVR | Standard Deviation 0.296 |
Comparison: The baseline neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.p-value: 0.0001Wilcoxon (Mann-Whitney)
Comparison: The 12 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.p-value: 0.0011Wilcoxon (Mann-Whitney)
Comparison: The 24 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.p-value: 0.0008Wilcoxon (Mann-Whitney)
Secondary
Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress
At each study time point (baseline, 12 months and 24 months) PET images were obtained at 45 min and again at 90 post injection. These images were assigned a BAPL score of 1, 2 or 3 based on the reader's evaluation of the scan. A BAPL scores of 1 was considered normal, and scores of 2 and 3 were considered abnormal. These scores were compared to subjects clinical diagnosis for AD at the end of the study follow up period.
Time frame: 2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months
Population: All subjects with PET data at the referenced study time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Not Progressed to AD (Baseline) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min normal PET assessment | 15 participants |
| Not Progressed to AD (Baseline) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min abnormal PET assessment | 11 participants |
| Not Progressed to AD (Baseline) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min normal PET assessment | 16 participants |
| Not Progressed to AD (Baseline) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min abnormal PET assessment | 10 participants |
| Progressed to AD (Baseline) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min normal PET assessment | 0 participants |
| Progressed to AD (Baseline) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min abnormal PET assessment | 17 participants |
| Progressed to AD (Baseline) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min normal PET assessment | 2 participants |
| Progressed to AD (Baseline) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min abnormal PET assessment | 19 participants |
| Not Progressed to AD (12 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min abnormal PET assessment | 10 participants |
| Not Progressed to AD (12 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min normal PET assessment | 14 participants |
| Not Progressed to AD (12 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min abnormal PET assessment | 8 participants |
| Not Progressed to AD (12 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min normal PET assessment | 16 participants |
| Progressed to AD (12 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min normal PET assessment | 0 participants |
| Progressed to AD (12 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min abnormal PET assessment | 16 participants |
| Progressed to AD (12 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min abnormal PET assessment | 17 participants |
| Progressed to AD (12 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min normal PET assessment | 1 participants |
| Not Progressed to AD (24 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min normal PET assessment | 14 participants |
| Not Progressed to AD (24 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min abnormal PET assessment | 8 participants |
| Not Progressed to AD (24 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min abnormal PET assessment | 8 participants |
| Not Progressed to AD (24 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min normal PET assessment | 14 participants |
| Progressed to AD (24 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min abnormal PET assessment | 14 participants |
| Progressed to AD (24 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min normal PET assessment | 2 participants |
| Progressed to AD (24 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 90 min abnormal PET assessment | 12 participants |
| Progressed to AD (24 Month) | Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress | 45 min normal PET assessment | 0 participants |
Secondary
Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4
This outcome measure showed the number of abnormal scans in subjects with MCI progressing to AD and those who did not progress compared to subjects with normal scans that did not progress and those who did progress.
Time frame: 1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months
Population: All subjects receiving study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Not Progressed to AD (Baseline) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Normal Scan | 17 participants |
| Not Progressed to AD (Baseline) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Abnormal Scan | 9 participants |
| Progressed to AD (Baseline) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Normal Scan | 2 participants |
| Progressed to AD (Baseline) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Abnormal Scan | 17 participants |
| Not Progressed to AD (12 Month) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Normal Scan | 15 participants |
| Not Progressed to AD (12 Month) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Abnormal Scan | 9 participants |
| Progressed to AD (12 Month) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Normal Scan | 2 participants |
| Progressed to AD (12 Month) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Abnormal Scan | 16 participants |
| Not Progressed to AD (24 Month) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Normal Scan | 12 participants |
| Not Progressed to AD (24 Month) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Abnormal Scan | 10 participants |
| Progressed to AD (24 Month) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Normal Scan | 1 participants |
| Progressed to AD (24 Month) | Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 | Number with Abnormal Scan | 13 participants |
Secondary
Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress
Sensitivity, specificity, NPV and PPV were measured based on subject BAPL scores by time point and imaging window, compared to clinical diagnosis of AD during the study period. A BAPL score of 1 was considered negative for the presence of beta-amyloid, and scores of 2 and 3 were considered positive. For this study, sensitivity was defined as the percentage of subjects with a clinical diagnosis of AD who also had a positive PET scan (BAPL score of 2 or 3) at the respective time point. Specificity was defined as the percentage of subjects with a clinical diagnosis of non-AD who also had a negative PET scan (BAPL score of 0 or 1) at the respective time point. PPV was defined as the probability that a subject with a positive PET scan would have a clinical diagnosis of AD sometime during the 2 year follow up period. NPV was defined as the probability that a subject with a negative PET scan would not have a clinical diagnosis of AD at any point during the 2 year follow up period.
Time frame: 2 scanning periods post injection to be evaluated at baseline
Population: All subjects with PET data at the referenced study time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Not Progressed to AD (Baseline) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Sensitivity | 89.47 percentage of subjects |
| Not Progressed to AD (Baseline) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Specificity | 57.69 percentage of subjects |
| Not Progressed to AD (Baseline) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Positive Predictive value | 60.71 percentage of subjects |
| Not Progressed to AD (Baseline) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Negative predictive value | 88.24 percentage of subjects |
| Progressed to AD (Baseline) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Positive Predictive value | 65.52 percentage of subjects |
| Progressed to AD (Baseline) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Specificity | 61.54 percentage of subjects |
| Progressed to AD (Baseline) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Sensitivity | 100.00 percentage of subjects |
| Progressed to AD (Baseline) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Negative predictive value | 100.00 percentage of subjects |
| Not Progressed to AD (12 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Negative predictive value | 100.00 percentage of subjects |
| Not Progressed to AD (12 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Positive Predictive value | 68.00 percentage of subjects |
| Not Progressed to AD (12 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Specificity | 66.67 percentage of subjects |
| Not Progressed to AD (12 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Sensitivity | 100.00 percentage of subjects |
| Progressed to AD (12 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Sensitivity | 94.12 percentage of subjects |
| Progressed to AD (12 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Negative predictive value | 93.33 percentage of subjects |
| Progressed to AD (12 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Specificity | 58.33 percentage of subjects |
| Progressed to AD (12 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Positive Predictive value | 61.54 percentage of subjects |
| Not Progressed to AD (24 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Positive Predictive value | 63.64 percentage of subjects |
| Not Progressed to AD (24 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Negative predictive value | 100.00 percentage of subjects |
| Not Progressed to AD (24 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Specificity | 63.64 percentage of subjects |
| Not Progressed to AD (24 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Sensitivity | 100.00 percentage of subjects |
| Progressed to AD (24 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Specificity | 63.64 percentage of subjects |
| Progressed to AD (24 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Positive Predictive value | 60.00 percentage of subjects |
| Progressed to AD (24 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Negative predictive value | 87.50 percentage of subjects |
| Progressed to AD (24 Month) | Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress | Sensitivity | 85.71 percentage of subjects |