Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD subjects | Experimental |
| |
| MCI Subjects | Experimental | MCI (mild cognitive impairment) |
|
| Healthy controls | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | IV injection, 370MBq (10mCi), single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Amyloid Image Assessment | Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation. | 50-60 min after injection |
| Mean Cortical to Cerebellum SUVR | Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. | 50-60 min after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Positive Florbetapir-PET Scans | Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups. | 50-60 min after injection |
Not provided
Inclusion Criteria AD:
Inclusion Criteria MCI:
Normal subjects:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85006 | United States | ||
| Research Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AD Subjects | Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria |
| FG001 | MCI Subjects |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Scottsdale |
| Arizona |
| 85252 |
| United States |
| Research Site | Sun City | Arizona | 85210 | United States |
| Research Site | Tucson | Arizona | 85741 | United States |
| Research Site | Costa Mesa | California | 92626 | United States |
| Research Site | New Haven | Connecticut | 06510 | United States |
| Research Site | Hallandale | Florida | 33064 | United States |
| Research Site | Miami Beach | Florida | 33140 | United States |
| Research Site | St. Petersburg | Florida | 33702 | United States |
| Research Site | Sunrise | Florida | 33351 | United States |
| Research Site | West Palm Beach | Florida | 33407 | United States |
| Research Site | Albany | New York | 12208 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Jenkintown | Pennsylvania | 19046 | United States |
| Research Site | Bennington | Vermont | 05201 | United States |
MCI (mild cognitive impairment)
| FG002 | Healthy Controls | cognitively normal (healthy) controls |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AD Subjects | Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria |
| BG001 | MCI Subjects | MCI (mild cognitive impairment) |
| BG002 | Healthy Controls | cognitively normal (healthy) controls |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Qualitative Amyloid Image Assessment | Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation. | One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population. | Posted | Number | participants | 50-60 min after injection |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Positive Florbetapir-PET Scans | Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups. | One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population. | Posted | Number | percentage of amyoid positive scans | 50-60 min after injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Cortical to Cerebellum SUVR | Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. | One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population. | Posted | Mean | Standard Deviation | SUVR | 50-60 min after injection |
|
|
AEs were collected up to 7 days after injection. SAEs were collected up to 30 days after injection.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | All subjects receiving florbetapir F 18 injection | 1 | 184 | 2 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-298-0700 | clinicaloperations@avidrp.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C545186 | florbetapir |
Not provided
Not provided
Not provided
| Male |
|
|
| Fisher Exact |
| <0.0001 |
| 95 |
| No |
| Superiority or Other |
| Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups | Fisher Exact | 0.0014 | 95 | No | Superiority or Other |
| Participants |
|
|
|
|