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A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the preclinical, prodromal and dementia phases of Alzheimer's disease.
The Australian Imaging Biomarkers and Lifestyle Study (AIBL) is a multicenter multidisciplinary study of Alzheimer's disease and aging funded by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Flagship Initiative, involving research centers in both Victoria and Western Australia. The goal of the A08 protocol was to further investigate the positron emission tomography (PET) imaging results with flortaucipir in patients across the AD spectrum from individuals with subjective memory complaints (SMC) to those with dementia, based on recruitment into the parent AIBL study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alzheimer's disease (AD) | Experimental | Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months |
|
| Mild cognitive impairment (MCI) | Experimental | Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months |
|
| Subjective memory complainers (SMC) | Experimental | Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months |
|
| Cognitively normal (CN) | Experimental | Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flortaucipir F18 | Drug | IV injection, 240 megabecquerel (MBq) (6.5 mCi) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flortaucipir PET Imaging (Quantitative) | Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | baseline scan |
| Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status | Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study. | baseline scan |
| Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status | Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study. | baseline scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals, Inc. | Study Director |
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| Label | URL |
|---|---|
| Link to the Australian Imaging, Biomarker \& Lifestyle Flagship Study of Ageing (AIBL) website | View source |
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Enrollment occurred between Oct 2014 and Feb 2018 from the Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL)
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| ID | Title | Description |
|---|---|---|
| FG000 | Alzheimer's Disease (AD) | Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months |
| FG001 | Mild Cognitive Impairment (MCI) | Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months |
| FG002 | Subjective Memory Complainers (SMC) | Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months |
| FG003 | Cognitively Normal (CN) | Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alzheimer's Disease (AD) | Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months |
| BG001 | Mild Cognitive Impairment (MCI) | Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months |
| 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 PET Imaging (Quantitative) | Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | Inclusion in this analysis required that the subject's flortaucipir scan was analyzable for SUVr (1 AD, 1 MCI, 5 SMC, and 3 CN were not analyzable) | Posted | Least Squares Mean | Standard Error | standardized uptake value ratio (SUVr) | baseline scan |
|
End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
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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 (AD) | Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | MedDRA (17.0) | 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 | Feb 28, 2014 | Jul 27, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2018 | Jul 27, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| 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 |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| BG002 | Subjective Memory Complainers (SMC) | Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months |
| BG003 | Cognitively Normal (CN) | Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mini Mental Status Exam (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 |
|
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months |
| OG002 | Objectively Impaired | Combined AD and MCI group |
| OG003 | Subjective Memory Complainers (SMC) | Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months |
| OG004 | Cognitively Normal (CN) | Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months |
| OG005 | Non-objectively Compared | Combined SMC and CN groups |
|
|
|
| Primary | Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status | Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study. | Rows display flortaucipir scan results by subjects who were amyloid positive and amyloid negative at baseline | Posted | Count of Participants | Participants | baseline scan |
|
|
|
|
| Primary | Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status | Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study. | Rows display flortaucipir scan results by subjects who were amyloid positive and amyloid negative at baseline. | Posted | Count of Participants | Participants | baseline scan |
|
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Mild Cognitive Impairment (MCI) | Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Subjective Memory Complainers (SMC) | Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months | 0 | 45 | 0 | 45 | 1 | 45 |
| EG003 | Cognitively Normal (CN) | Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months | 0 | 25 | 0 | 25 | 1 | 25 |
| dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
|
| Amyloid Negative |
|
|
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| Amyloid Negative |
|
|
| Not Advanced AD Pattern |
|
| Not AD Pattern Scan |
|