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| Name | Class |
|---|---|
| American College of Radiology Imaging Network | NETWORK |
| General Electric | INDUSTRY |
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This study will evaluate the performance characteristics of a novel [18F] amyloid detection ligand (18F]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of [11C]PIB to correctly categorize the same subjects.
SPECIFIC HYPOTHESES
15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both [18F]-AV-45 and [11C]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic category, ligand retention will be evaluated with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and tau.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | 370 MBq (10 mCi), intravenous (IV) injection, single dose |
| |
| [11C]-PIB | Drug | 555 MBq (15 mCi), IV injection, single dose [11C]-PIB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. | Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum. | 28 d |
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Inclusion Criteria:
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 | Alzheimer's Disease | Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90 |
| FG001 | Healthy Controls | Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alzheimer's Disease | Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90 |
| BG001 | Healthy Controls |
| 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 | Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. | Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum. | Posted | Mean | Standard Deviation | SUVR | 28 d |
|
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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 | Alzheimer's Disease | Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Disturbance | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-298-0700 | clinicaloperations@avidrp.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
| C475519 | 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole |
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Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years. |
|
|
| 0 |
| 13 |
| 4 |
| 13 |
| EG001 | Healthy Controls | Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years. | 0 | 15 | 1 | 15 |
| Injection Site Pain | General disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Hypertension | Vascular disorders |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |