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| ID | Type | Description | Link |
|---|---|---|---|
| 5R43NS063607-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal cognitive performance | Experimental | Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores of ≥9, indicating normal cognitive performance. |
|
| Mild cognitive deficits | Experimental | Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores between 6 and 8, inclusive, indicating mild cognitive deficits. |
|
| Severe cognitive impairment | Experimental | Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores below 5, indicating moderate to severe cognitive impairment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | 10 millicurie (mCi) (370 MBq) florbetapir F 18 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cortical Amyloid Burden | Standardized uptake value ratios (SUVR) were calculated and compared between subjects with PD and controls. Subjects with Parkinson's Disease (PD) were stratified into one of three groups based on performance on the age and education adjusted Mattis Dementia Rating Scale (DRS-2). The age and education adjusted DRS-2 ranges from 0 (lowest cognitive function) to 20 (highest cognitive function). SUVR is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the predefined cortical regions as compared to cerebellum whereas scores less than 1 indicate the opposite. This outcome measure only reports data from the subjects analyzed in this study, the data from normal controls was obtained from a pre-existing database and is not reported here. | 50-60 min after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline. | Correlation between amyloid burden (global florbetapir SUVR) and cognitive decline (DRS-2 score) was determined using Spearman's rank order correlation method where SUVR was the dependent variable and the DRS-2 score was the independent variable. This analysis was performed for total DRS-2 score and the five DRS-2 subscale scores. The subscales (score range) are: Attention (0-37), Initiation/Perseveration (0-37), Construction (0-6), Conceptualization (0-39) and Memory (0-25). The total DRS-2 score is the sum of the subscale scores and ranges from 0-144. Higher DRS-2 scores indicate greater cognitive function. |
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Inclusion Criteria:
Subjects may be enrolled if they (inclusion criteria):
Are males or females ≥60 years of age
Meet research diagnostic criteria for Parkinson's disease:
Diagnosis of a parkinsonian syndrome
Supportive criteria for diagnosis of PD (two or more required)
Have the ability to lie flat and tolerate a 10 minute PET scan.
Exclusion Criteria:
Subjects may not be enrolled if any of the following are present (exclusion criteria):
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Parkinson's Disease | Subjects with diagnosed Parkinson's Disease received a 370 megabecquerel (MBq) injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Parkinson's Disease | Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Cortical Amyloid Burden | Standardized uptake value ratios (SUVR) were calculated and compared between subjects with PD and controls. Subjects with Parkinson's Disease (PD) were stratified into one of three groups based on performance on the age and education adjusted Mattis Dementia Rating Scale (DRS-2). The age and education adjusted DRS-2 ranges from 0 (lowest cognitive function) to 20 (highest cognitive function). SUVR is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the predefined cortical regions as compared to cerebellum whereas scores less than 1 indicate the opposite. This outcome measure only reports data from the subjects analyzed in this study, the data from normal controls was obtained from a pre-existing database and is not reported here. | All subjects who were enrolled in the study and received florbetapir scans. | Posted | Mean | Standard Deviation | SUVR | 50-60 min after injection |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Parkinson's Disease | Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals, Inc. | 215-298-0700 | clinicaloperations@avidrp.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
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|
| 50-60 min after injection |
| Correlation of Florbetapir SUVR With CSF Biomarker Values | Correlation between amyloid burden (florbetapir SUVR) and cerebrospinal fluid (CSF) biomarker values (amyloid beta, tau and phospho-tau) was determined using Spearman's rank order correlation in a subset of subjects undergoing CSF analysis where SUVR was the dependent variable and CSF biomarker values were the independent variables. | 50-60 min after injection |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Subjects With Normal Cognitive Performance |
Subjects have an age-and education-adjusted standardized Mattis DRS-2 score greater than or equal to 9. |
| OG001 | Subjects With Mild Cognitive Deficits | Subjects have an age-and education-adjusted standardized Mattis DRS-2 score between 6 and 8 inclusive. |
| OG002 | Subjects With Moderate to Severe Cognitive Impairment | Subjects have an age-and education-adjusted standardized Mattis DRS-2 score 5 and below. |
|
|
| Secondary | Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline. | Correlation between amyloid burden (global florbetapir SUVR) and cognitive decline (DRS-2 score) was determined using Spearman's rank order correlation method where SUVR was the dependent variable and the DRS-2 score was the independent variable. This analysis was performed for total DRS-2 score and the five DRS-2 subscale scores. The subscales (score range) are: Attention (0-37), Initiation/Perseveration (0-37), Construction (0-6), Conceptualization (0-39) and Memory (0-25). The total DRS-2 score is the sum of the subscale scores and ranges from 0-144. Higher DRS-2 scores indicate greater cognitive function. | All subjects who were enrolled in the study and received florbetapir scans. | Posted | Number | Correlation Coefficient | 50-60 min after injection |
|
|
|
|
| Secondary | Correlation of Florbetapir SUVR With CSF Biomarker Values | Correlation between amyloid burden (florbetapir SUVR) and cerebrospinal fluid (CSF) biomarker values (amyloid beta, tau and phospho-tau) was determined using Spearman's rank order correlation in a subset of subjects undergoing CSF analysis where SUVR was the dependent variable and CSF biomarker values were the independent variables. | Participants were a subset of all subjects enrolled in this study who were also part of an ongoing study looking at the usefulness of CSF biomarkers. | Posted | Number | Correlation Coefficient | 50-60 min after injection |
|
|
|
|
| 0 |
| 31 |
| 4 |
| 31 |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Title | Measurements |
|---|---|
|
| Conceptualization |
|
| Memory |
|
| DRS-2 Total Score |
|
| Spearman's Rank Order Correlation |
| 0.077 |
| 95 |
| No |
| Superiority or Other |
| P-value for "Construction" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 construction score. | Spearman's Rank Order Correlation | 0.364 | 95 | No | Superiority or Other |
| P-value for "Conceptualization" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 conceptualization score. | Spearman's Rank Order Correlation | 0.266 | 95 | No | Superiority or Other |
| P-value for "Memory" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 memory score. | Spearman's Rank Order Correlation | 0.152 | 95 | No | Superiority or Other |
| P-value for "DRS-2 Total" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 total score. | Spearman's Rank Order Correlation | 0.041 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Spearman's Rank Order Correlation |
| 0.5800 |
| 95 |
| No |
| Superiority or Other |
| P-value for "Phospho-Tau" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and phospho-tau. | Spearman's Rank Order Correlation | 0.8164 | 95 | No | Superiority or Other |