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This protocol is designed to serve as a pre-screening study for subjects who are potentially eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|---|---|---|
| Flortaucipir Qualitative Results (Visual Reads) | Flortaucipir PET scans were rated visually by an expert reader as follows: Not consistent with an AD pattern (τAD-), Moderate AD pattern (τAD+), or Advanced AD pattern and likely to progress (τAD++). Eligibility for AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria. | baseline scan |
| Flortaucipir Quantitative Results (SUVr) | Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. Visual read categories as described for previous measure. Eligibility for AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria. | baseline scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Research Network | San Diego | California | 92103 | United States | ||
| Syrentis Clinical Research |
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Enrollment occurred between Nov 2017 and Aug 2018. Recruited subjects with clinically diagnosed early AD who were interested in participating in AD therapeutic clinical trial AACG (Eli Lilly and Company; TRAILBLAZER-ALZ; NCT03367403)
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Symptomatic AD Subjects | Early Symptomatic AD subjects in the flortaucipir PET scan arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Symptomatic AD Subjects | Early Symptomatic AD subjects in the flortaucipir PET scan arm |
| 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 | Flortaucipir Qualitative Results (Visual Reads) | Flortaucipir PET scans were rated visually by an expert reader as follows: Not consistent with an AD pattern (τAD-), Moderate AD pattern (τAD+), or Advanced AD pattern and likely to progress (τAD++). Eligibility for AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria. | Includes all subjects who completed the study with valid flortaucipir PET scan (n=152) | Posted | Count of Participants | Participants | baseline scan |
|
48 hours after study drug administration
Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. 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 | Safety Analysis Population | All subjects with early symptomatic AD from the flortaucipir PET scan arm who received one dose of flortaucipir |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | 215-298-0700 | clinicaloperations@avidrp.com |
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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 | Sep 11, 2017 | Jun 27, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2018 | Jun 27, 2020 | SAP_001.pdf |
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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 |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
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| Brain PET Scan | Procedure | positron emission tomography (PET) scan of the brain |
|
| Santa Ana |
| California |
| 92705 |
| United States |
| Brain Matters Research | Delray Beach | Florida | 33445 | United States |
| Bioclinica (Compass Research) | Orlando | Florida | 32806 | United States |
| Axiom Clinical Research | Tampa | Florida | 33609 | United States |
| Boston Center for Memory | Newton | Massachusetts | 02459 | United States |
| PMG Research | Winston-Salem | North Carolina | 27103 | United States |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | United States |
| The Memory Clinic | Bennington | Vermont | 05201 | United States |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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 |
|
| Early Symptomatic AD, Ineligible for AACG Study |
Subjects who were not eligible for the AACG Study from the flortaucipir PET scan arm. |
| OG002 | Early Symptomatic AD (Total) | All subjects with early symptomatic AD from the flortaucipir PET scan arm |
|
|
| Primary | Flortaucipir Quantitative Results (SUVr) | Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. Visual read categories as described for previous measure. Eligibility for AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria. | SUVr was not collected for patients with a τAD- result | Posted | Mean | Standard Deviation | standardized uptake value ratio (SUVr) | baseline scan |
|
|
|
| 0 |
| 155 |
| 0 |
| 155 |
| 2 |
| 155 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| SUVr τAD++ subjects |
|
|
| SUVr τAD+ subjects |
|
|