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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03901105
Registration number
NCT03901105
Ethics application status
Date submitted
28/03/2019
Date registered
3/04/2019
Date last updated
28/08/2020
Titles & IDs
Public title
Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease
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Scientific title
Evaluation of the Relationship Between Baseline Flortaucipir PET Signal and Cognitive Change in Subjects With Early Alzheimer's Disease Participating in the I8D-MC-AZES Protocol Addendum D5010C00009 (2.1) (Tau Imaging)
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Secondary ID [1]
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18F-AV-1451-PX01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - flortaucipir F18
Treatment: Surgery - Brain PET Scan
Experimental: Flortaucipir PET Scan - 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.
Treatment: Drugs: flortaucipir F18
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
Treatment: Surgery: Brain PET Scan
positron emission tomography (PET) scan of the brain
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Risk Ratio for AD Symptom Progression on CDR-SB
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Assessment method [1]
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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.
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Timepoint [1]
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Within 18 months of scan
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Secondary outcome [1]
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Risk Ratio for AD Symptom Progression on Various Clinical Measures
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Assessment method [1]
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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.
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Timepoint [1]
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Within 18 months of scan
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Secondary outcome [2]
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Mean Change in Cognitive/Functional Assessments
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Assessment method [2]
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Mean change in cognitive/functional measures baseline between tAD++ and non-tAD++ (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.
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Timepoint [2]
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baseline and 18 months
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Secondary outcome [3]
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Inter-Reader Reliability of Reader Interpretation of Flortaucipir F 18 PET Imaging
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Assessment method [3]
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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 tAD++ or non-tAD++.
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Timepoint [3]
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baseline scan
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Eligibility
Key inclusion criteria
Scan Reader Criteria (5 total readers):
- Board-certified in radiology or nuclear medicine
- Professional experience interpreting PET scans
Scan Criteria (205 total scans):
- Former enrollment in AZES Study
- Flortaucipir scan at baseline
- clinical dementia rating - sum of boxes (CDR-SB) assessment at 18 months
Scan Study Population (AZES Study):
- 55 to 85 years
- MCI due to AD or probable AD by National Institute on Aging-Alzheimer's Association
criteria (Albert 2011
- mini-mental status exam (MMSE) of 20 to 30 inclusive
- CDR global score of 0.5 (MCI), or 0.5 or 1 (AD) with a memory box score = 0.5, and a
score of =85 on the Delayed Memory Index of the Repeatable Battery for the Assessment
of Neuropsychological Status.
- Amyloid positive status confirmed by florbetapir PET or lumbar puncture
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Minimum age
55
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/04/2019
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Sample size
Target
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Accrual to date
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Final
205
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Pennsylvania
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Avid Radiopharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03901105
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Study Director
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Address
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Avid Radiopharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03901105
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