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This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up Flortaucipir PET Scan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flortaucipir F18 | Drug | 370 megabecquerel (MBq) IV single-dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status | Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | United States | ||
| Imaging Endpoints |
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Enrolled between Aug 2016 and Aug 2017. The only subjects eligible were those who completed the Confirmatory Phase of Study A05 (NCT02016560).
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| ID | Title | Description |
|---|---|---|
| FG000 | AD Subjects | Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 |
| FG001 | MCI Subjects | Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2016 | Jun 27, 2020 |
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| PET Scan | Procedure | positron emission tomography (PET) scan |
|
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States |
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | United States |
| Institute for Brain Aging and Dementia, UC Irvine | Irvine | California | 92697 | United States |
| 21st Century Oncology | Newport Beach | California | 92663 | United States |
| Alzheimer's Disease Center, UC Davis | Sacramento | California | 95817 | United States |
| California Medical Clinic for Headache | Santa Monica | California | 90404 | United States |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | 33912 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| University of South Florida Health Byrd Alzheimer's Institute | Tampa | Florida | 33613 | United States |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Las Vegas Radiology | Las Vegas | Nevada | 89113 | United States |
| New York University Center for Brain Health | New York | New York | 10016 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AD Subjects | Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 from the flortaucipir PET scan arm |
| BG001 | MCI Subjects | Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 from the flortaucipir PET scan arm |
| BG002 | 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| MMSE | Mini-mental status exam (MMSE) is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| CDR-SB | The CDR scale (Berg 1988) examines 6 cognitive functioning domains individually on a scale of 0 to 3. CDR Sum of Boxes (CDR-SB) is generated by summing the total score across domains. Scores range from 0 to 18, with higher scores indicating higher levels of cognitive impairment. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Amyloid status | Amyloid status (positive/negative) determined by florbetapir PET | Count of Participants | Participants |
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| 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 | Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status | Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05. | Excluded 1 MCI Aβ+ and 1 MCI Aβ- subject for whom 18 month follow-up clinical was not available | Posted | Least Squares Mean | Standard Deviation | standardized uptake value ratio (SUVr) | 18 months |
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48 hours after study drug administration
Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.
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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 | MCI Subjects | MCI subjects receiving a dose of flortaucipir | 0 | 54 | 0 | 54 | 2 | 54 |
| EG001 | AD Subjects | AD subjects receiving a dose of flortaucipir | 0 | 25 | 0 | 25 | 0 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| injection site pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| flushing | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | 215-298-0700 | clinicaloperations@avidrp.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2018 | Jun 27, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| 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 |
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| ID | Term |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Amyloid Negative |
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Test of whether difference in least squares mean change is 0 |
| ANCOVA |
Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI) |
| 0.0108 |
No adjustments for multiplicity. No a priori threshold defined. |
| Other |