Clinical Trial Results:
Validating in vivo quantification of tau with [18F]AV-1451 PET
Summary
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EudraCT number |
2015-004230-10 |
Trial protocol |
NL |
Global end of trial date |
08 Nov 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Dec 2021
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First version publication date |
13 Dec 2021
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Other versions |
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Summary report(s) |
Published paper |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
15-14
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
VU University Medical Center
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Sponsor organisation address |
De Boellelaan 1117, Amsterdam, Netherlands, 1081 HV
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Public contact |
Dept of Radiology Nuclear Medicine, VU University Medical Center, 0031 204441948, t.timmers@vumc.nl
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Scientific contact |
Dept of Radiology Nuclear Medicine, VU University Medical Center, 0031 204441948, t.timmers@vumc.nl
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Sep 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
08 Nov 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Nov 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To validate the previously defined simplified tracer kinetic model to quantify specific binding of [18F]AV-1451
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Protection of trial subjects |
No trial specific measures were put in place. Regular procedures regarding scanning and puncture procedures were in place.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Dec 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 14
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Worldwide total number of subjects |
14
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EEA total number of subjects |
14
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
6
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
All AD patients will be recruited from the memory clinic of the VUmc Alzheimer Center Amsterdam. Annually, the Alzheimer Center receives 600 new patients. Control subjects will be recruited through advertisements in newspapers and by means of flyers. | ||||||
Pre-assignment
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Screening details |
Inclusion criteria included: Amyloid positive MCI or AD patients over the age of 50, with a MMSE above 17, able to tolerate scanning procedures. Or 50+ CN subjects able to tolerate scanning procedures | ||||||
Period 1
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Period 1 title |
test
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Overall study | ||||||
Arm description |
NA | ||||||
Arm type |
18F-AV1451 scan | ||||||
Investigational medicinal product name |
[18F]AV1451
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
240 MBq via intravenous injection
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Period 2
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Period 2 title |
retest
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Is this the baseline period? |
No | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Overall study | ||||||
Arm description |
- | ||||||
Arm type |
overall study | ||||||
Investigational medicinal product name |
[18F]AV1451
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
240 MBq via intravenous injection
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Baseline characteristics reporting groups
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Reporting group title |
test
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Reporting group description |
8 MCI/AD subjects and 6 CN controls were reqruited and scanned with [18F]AV1451 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Overall study
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Reporting group description |
NA | ||
Reporting group title |
Overall study
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Reporting group description |
- |
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End point title |
test-retest variability of the previously defined simplified tracer kinetic model to quantify specific binding of [18F]AV-1451 | |||||||||
End point description |
For all methods and across ROIs, TRT repeatability ranged from (median (IQR)) 0.84% (0.68–2.15) to 6.84% (2.99–11.50).
TRT repeatability was good for all reference methods used, although semi-quantitative models (i.e. SUVr) performed
marginally worse than quantitative models, for instance TRT repeatability of RPM: 1.98% (0.78–3.58) vs. SUVr80–100:
3.05% (1.28–5.52), p<0.001. The count for RPM method is provided, given that that is the most used method.
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End point type |
Primary
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End point timeframe |
Test-retest repeatability
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Statistical analysis title |
Main statistics | |||||||||
Statistical analysis description |
TRT repeatability (%) was defined as jretest–testj/
(average (testþretest))100. For RPM and STRM2,
TRT repeatability was assessed using BPNDþ1, corresponding
to DVR, in order to directly compare values to
RLogan and SUVr methods. To compare TRT repeatability
per reference region method (RLogan, RPM,
SRTM2, SUVr for 3 time intervals) and to compare
TRT repeatability per tau-specific region (MTL, LTL
and global ROI), we used Kruskal–Wallis tests and
post-hoc Mann–Whitney U testing with B
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Comparison groups |
Overall study v Overall study
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Number of subjects included in analysis |
28
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
< 0.05 [1] | |||||||||
Method |
Kruskal-wallis | |||||||||
Confidence interval |
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Notes [1] - With Bonferroni correction |
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Adverse events information [1]
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Timeframe for reporting adverse events |
All adverse events, which occur 48 hours after administration of the radioactive tracer, and are reported spontaneously by the subject or observed by the investigator or his staff will be recorded.
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
VUmc/CRB | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No no-serious adverse events were reported during the study |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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15 Mar 2018 |
Wijzigingen in het studieprotocol: tijdens de screening wordt geen ECG en geen lab verricht, er wordt geen arterieel bloed meer afgenomen, ook patiënten met MCI op basis van de ziekte van Alzheimer worden geïncludeerd.
Wijzigingen in de informatiebrief en het IC: aanpassingen voor de proefpersoon zoals boven beschreven, en vrouwen mogen tot 24u na de PET scan niet zwanger worden. Voor mannen gelden geen restricties.
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/31575335 |