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Comparison of PET Amyloid Imaging in Japanese and Western Subjects

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ClinicalTrials.gov Identifier: NCT02813070
Recruitment Status : Completed
First Posted : June 24, 2016
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Mild Cognitive Impairment
Alzheimer's Disease
Healthy
Intervention Drug: [18F] Flutemetamol
Enrollment 70
Recruitment Details The study was conducted at 5 centers in Japan and 1 center in Korea. A total of 87 participants were enrolled and screened in the study, of whom, 17 withdrew prior to dosing and 70 participants received Flutemetamol F 18 injection.
Pre-assignment Details Participants were assigned into 3 groups based on the baseline diagnosis of probable Alzheimer’s disease (pAD), amnestic mild cognitive impairment (aMCI) or healthy volunteers (HVs). All screened participants underwent diagnostic-quality anatomic brain magnetic resonance imaging (MRI) during screening period.
Arm/Group Title Participants With Probable Alzheimer's Disease Participants With Amnestic Mild Cognitive Impairment Healthy Volunteers
Hide Arm/Group Description Participants with baseline diagnosis of probable Alzheimer's disease (pAD), received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent Positron emission tomography (PET) imaging. Participants with baseline diagnosis of amnestic mild cognitive impairment (aMCI), received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging. Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
Period Title: Overall Study
Started [1] 28 23 36
Treated (Safety Population) 25 20 25
Completed 25 20 25
Not Completed 3 3 11
[1]
Screened participants
Arm/Group Title Participants With Probable Alzheimer's Disease Participants With Amnestic Mild Cognitive Impairment Healthy Volunteers Total
Hide Arm/Group Description Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging. Participants with baseline diagnosis of aMCI, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging. Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging. Total of all reporting groups
Overall Number of Baseline Participants 25 20 25 70
Hide Baseline Analysis Population Description
Baseline population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 20 participants 25 participants 70 participants
74.8  (6.04) 71.2  (7.28) 57.4  (9.24) 67.5  (10.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 20 participants 25 participants 70 participants
Female
16
  64.0%
9
  45.0%
11
  44.0%
36
  51.4%
Male
9
  36.0%
11
  55.0%
14
  56.0%
34
  48.6%
1.Primary Outcome
Title Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Hide Description The performance of Flutemetanol F 18 injection in participants was determined by evaluation of the level of association between the blinded visual assessment of a participant’s brain image and the participant’s clinical diagnosis by 5 non-Japanese readers, who classified each participant’s images as either normal or abnormal (raised) Flutemetanol F 18 uptake.
Time Frame Up to 90 minutes after investigational medicinal product (IMP) administration
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of all participants who had evaluable images following Flutemetamol F 18 injection and evaluable anatomic MRI images. As prospectively planned in the protocol, only participants enrolled with a clinical diagnosis of HV or pAD were included in the analysis of the primary endpoint.
Arm/Group Title Participants With Probable Alzheimer's Disease Healthy Volunteers
Hide Arm/Group Description:
Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal (positive) participants by Reader A
23
  92.0%
0
   0.0%
Normal (negative) participants by Reader A
2
   8.0%
25
 100.0%
Abnormal (positive) participants by Reader B
23
  92.0%
0
   0.0%
Normal (negative) participants by Reader B
2
   8.0%
25
 100.0%
Abnormal (positive) participants by Reader C
23
  92.0%
0
   0.0%
Normal (negative) participants by Reader C
2
   8.0%
25
 100.0%
Abnormal (positive) participants by Reader D
23
  92.0%
0
   0.0%
Normal (negative) participants by Reader D
2
   8.0%
25
 100.0%
Abnormal (positive) participants by Reader E
23
  92.0%
1
   4.0%
Normal (negative) participants by Reader E
2
   8.0%
24
  96.0%
2.Primary Outcome
Title Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Hide Description The performance of Flutemetanol F 18 injection in participants was determined by evaluation of the level of association between the blinded visual assessment of a participant's brain image and the participant’s clinical diagnosis by 5 Japanese readers, who classified each participant's images as either normal or abnormal (raised) Flutemetanol F 18 uptake.
Time Frame Up to 90 minutes after IMP administration
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of all participants who had evaluable images following Flutemetamol F 18 injection and evaluable anatomic MRI images. As prospectively planned in the protocol, only participants enrolled with a clinical diagnosis of HV or pAD were included in the analysis of the primary endpoint.
Arm/Group Title Participants With Probable Alzheimer's Disease Healthy Volunteers
Hide Arm/Group Description:
Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal (positive) participants by Reader F
23
  92.0%
0
   0.0%
Normal (negative) participants by Reader F
2
   8.0%
25
 100.0%
Abnormal (positive) participants by Reader G
22
  88.0%
1
   4.0%
Normal (negative) participants by Reader G
3
  12.0%
24
  96.0%
Abnormal (positive) participants by Reader H
23
  92.0%
0
   0.0%
Normal (negative) participants by Reader H
2
   8.0%
25
 100.0%
Abnormal (positive) participants by Reader I
23
  92.0%
1
   4.0%
Normal (negative) participants by Reader I
2
   8.0%
24
  96.0%
Abnormal (positive) participants by Reader J
23
  92.0%
1
   4.0%
Normal (negative) participants by Reader J
2
   8.0%
24
  96.0%
Time Frame The safety of participants was monitored during the course of the study till 24-hours post administration of Flutemetanol F 18 injection.
Adverse Event Reporting Description Analysis was performed on safety population that included all participants who received any dose of Flutemetanol F 18 injection in the study.
 
Arm/Group Title Participants With Probable Alzheimer's Disease Participants With Amnestic Mild Cognitive Impairment Healthy Volunteers
Hide Arm/Group Description Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging. Participants with baseline diagnosis of aMCI, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging. Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
All-Cause Mortality
Participants With Probable Alzheimer's Disease Participants With Amnestic Mild Cognitive Impairment Healthy Volunteers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Probable Alzheimer's Disease Participants With Amnestic Mild Cognitive Impairment Healthy Volunteers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/20 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Participants With Probable Alzheimer's Disease Participants With Amnestic Mild Cognitive Impairment Healthy Volunteers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/20 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
Results Point of Contact
Name/Title: Paul Sherwin, M.D., PhD
Organization: GE Healthcare
Phone: +1-774-843-3888
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02813070     History of Changes
Other Study ID Numbers: GE067-017
First Submitted: June 15, 2016
First Posted: June 24, 2016
Results First Submitted: February 8, 2017
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017