A Phase 3 interventional study of flortaucipir F18 and Brain PET Scan in Alzheimer Disease, sponsored by Avid Radiopharmaceuticals. Completed at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-08-28.
Sponsored by Avid Radiopharmaceuticals · Phase 3, Interventional, and Diagnostic
This study will evaluate whether visual interpretation of flortaucipir-PET (positron emission tomography) scans, examining patterns of tracer uptake at baseline, can predict the rate of clinically-meaningful cognitive decline due to AD after 18 months. All scans are acquired from cohorts of a previously completed study, I8D-MC-AZES (NCT02245737, lanabecestat, Eli Lilly and Company sponsor).
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 205 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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Scan Reader Criteria (5 total readers):
Scan Criteria (205 total scans):
Scan Study Population (AZES Study):
No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) will be read by independent, blinded readers.
Drug: flortaucipir F18 · Procedure: Brain PET Scan
No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) at baseline will be read by independent, blinded readers. IV injection, 240 megabecquerel (MBq) (6.5 mCi), single dose in AZES
Also known as: 18F-AV-1451, [F-18]T807, LY3191748
positron emission tomography (PET) scan of the brain
Risk Ratio for AD Symptom Progression on CDR-SB
Baseline flortaucipir F 18 PET imaging results were determined by majority read (see Baseline Characteristics for description). Clinically meaningful deterioration (CMD) was defined for the primary endpoint as a worsening of the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score of one point or more. The clinical dementia rating (CDR) examines 6 categories of cognitive functioning domains. Each domain is scored on a scale ranging from 0 to 3 (including 0.5). A CDR-SB was generated as the sum of the values in each of the 6 domains. The CDR-SB sum scores range from 0 to 18, with higher scores indicating greater cognitive impairment and a 1 point worsening is considered a clinically significant symptom change.
Time frame: Within 18 months of scan
Risk Ratio for AD Symptom Progression on Various Clinical Measures
Baseline flortaucipir F 18 PET imaging results were determined by majority read (see Baseline Characteristics for description). Clinically meaningful deterioration (CMD) was defined for the cognitive endpoints as follows: mini-mental status exam (MMSE) worsening of 3 points or greater, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) worsening of 4 points or greater, Pfeffer's Functional Activities Questionnaire (FAQ) worsening of 3 points or greater, CDR global worsening of greater than 0 points. MMSE scores range from 0 to 30 with lower scores indicating worsening cognitive function. ADAS-Cog11 scores range from 0 to 70 with higher scores indicating worsening cognitive function. FAQ scores range from 0 to 30 with higher scores indicating worsening cognitive function. CDR global is scored on a 5 point scale (0, 0.5, 1, 2, 3) with higher scores indicating worsening cognitive function.
Time frame: Within 18 months of scan
Mean Change in Cognitive/Functional Assessments
Mean change in cognitive/functional measures baseline between τAD++ and non-τAD++ (determined by baseline tau status), calculated by Mixed Model Repeat Measures (MMRM). CDR-SB scores range from 0 to 18, with higher scores indicating worsening cognitive impairment. MMSE scores range from 0 to 30 with lower scores indicating worsening cognitive function. ADAS-Cog11 scores range from 0 to 70 with higher scores indicating worsening cognitive function. FAQ scores range from 0 to 30 with higher scores indicating worsening cognitive function.
Time frame: baseline and 18 months
Inter-Reader Reliability of Reader Interpretation of Flortaucipir F 18 PET Imaging
As measured by Fleiss' Kappa across all scans read. Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. Fleiss' kappa can range from -1 to 1 with 1 indicating perfect agreement between the readers. Read results binarized as τAD++ or non-τAD++.
Time frame: baseline scan
Scans were acquired from subjects previously enrolled in the AZES (NCT02245737) PET substudy (N=205), including mild AD (n=141) and mild cognitive impairment (MCI) due to AD (n=64).
| Milestone | All Subjects |
|---|---|
| Started | 205 |
| Completed | 205 |
| Not completed | 0 |
Baseline flortaucipir F 18 PET imaging results were determined by majority read (see Baseline Characteristics for description). Clinically meaningful deterioration (CMD) was defined for the primary endpoint as a worsening of the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score of one point or more. The clinical dementia rating (CDR) examines 6 categories of cognitive functioning domains. Each domain is scored on a scale ranging from 0 to 3 (including 0.5). A CDR-SB was generated as the sum of the values in each of the 6 domains. The CDR-SB sum scores range from 0 to 18, with higher scores indicating greater cognitive impairment and a 1 point worsening is considered a clinically significant symptom change.
| Participants | CMD (CDR-SB Change >=1) | No CMD |
|---|---|---|
| tAD++ | 119 | 43 |
| tAD+ | 10 | 5 |
| tAD- | 14 | 14 |
Baseline flortaucipir F 18 PET imaging results were determined by majority read (see Baseline Characteristics for description). Clinically meaningful deterioration (CMD) was defined for the cognitive endpoints as follows: mini-mental status exam (MMSE) worsening of 3 points or greater, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) worsening of 4 points or greater, Pfeffer's Functional Activities Questionnaire (FAQ) worsening of 3 points or greater, CDR global worsening of greater than 0 points. MMSE scores range from 0 to 30 with lower scores indicating worsening cognitive function. ADAS-Cog11 scores range from 0 to 70 with higher scores indicating worsening cognitive function. FAQ scores range from 0 to 30 with higher scores indicating worsening cognitive function. CDR global is scored on a 5 point scale (0, 0.5, 1, 2, 3) with higher scores indicating worsening cognitive function.
| Participants | CMD Yes | No CMD |
|---|---|---|
| MMSE — tAD++ | 112 | 49 |
| MMSE — tAD+ | 6 | 8 |
| MMSE — tAD- | 15 | 13 |
| ADAS-Cog — tAD++ | 98 | 59 |
| ADAS-Cog — tAD+ | 6 | 8 |
| ADAS-Cog — tAD- | 8 | 20 |
| FAQ — tAD++ | 111 | 47 |
| FAQ — tAD+ | 9 | 5 |
| FAQ — tAD- | 14 | 14 |
| CDR Global — tAD++ | 71 | 91 |
| CDR Global — tAD+ | 7 | 8 |
| CDR Global — tAD- | 9 | 19 |
Mean change in cognitive/functional measures baseline between τAD++ and non-τAD++ (determined by baseline tau status), calculated by Mixed Model Repeat Measures (MMRM). CDR-SB scores range from 0 to 18, with higher scores indicating worsening cognitive impairment. MMSE scores range from 0 to 30 with lower scores indicating worsening cognitive function. ADAS-Cog11 scores range from 0 to 70 with higher scores indicating worsening cognitive function. FAQ scores range from 0 to 30 with higher scores indicating worsening cognitive function.
| units on a scale | τAD++ Scan Result | Non-τAD++ Scan Result |
|---|---|---|
| CDR-SB | 2.22 ± 0.215 | 1.31 ± 0.379 |
| MMSE | -4.89 ± 0.377 | -2.12 ± 0.647 |
| ADAS-Cog11 | 6.53 ± 0.660 | 1.97 ± 1.181 |
| FAQ | 5.22 ± 0.537 | 2.68 ± 0.895 |
As measured by Fleiss' Kappa across all scans read. Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. Fleiss' kappa can range from -1 to 1 with 1 indicating perfect agreement between the readers. Read results binarized as τAD++ or non-τAD++.
| kappa coefficient | All Subjects/All Readers |
|---|---|
| Inter-Reader Reliability of Reader Interpretation of Flortaucipir F 18 PET Imaging | 0.754 (0.711 to 0.797) |
Collected over Not applicable, as no new patients received treatment as part of this study.. Non-serious events are listed at a 0.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm, Randomly Sequenced Flortaucipir F18 Scans | — | — | — |
| Age, Continuous(years) | All Scans |
|---|---|
| Mean | 71.0 ± 7.74 |
| Sex: Female, Male(Participants) | All Scans |
|---|---|
| Female | 100 |
| Male | 105 |
| Race (NIH/OMB)(Participants) | All Scans |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 27 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 172 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Flortaucipir PET Scan Result(Participants) | All Scans |
|---|---|
| tAD++ | 162 |
| tAD+ | 15 |
| tAD- | 28 |
| Mean CDR-SB(units on a scale) | All Scans |
|---|---|
| Mean | 3.69 ± 1.475 |
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Avid Radiopharmaceuticals