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Trial Outcomes & Findings for Comparison of PET Amyloid Imaging in Japanese and Western Subjects (NCT NCT02813070)

NCT ID: NCT02813070

Last Updated: 2017-06-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

Up to 90 minutes after investigational medicinal product (IMP) administration

Results posted on

2017-06-05

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
Participants With Probable Alzheimer's Disease
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 Amnestic Mild Cognitive Impairment
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
Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
Overall Study
STARTED
28
23
36
Overall Study
Treated (Safety Population)
25
20
25
Overall Study
COMPLETED
25
20
25
Overall Study
NOT COMPLETED
3
3
11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of PET Amyloid Imaging in Japanese and Western Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Participants With Probable Alzheimer's Disease
n=25 Participants
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 Amnestic Mild Cognitive Impairment
n=20 Participants
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
n=25 Participants
Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
Total
n=70 Participants
Total of all reporting groups
Age, Continuous
74.8 years
STANDARD_DEVIATION 6.04 • n=5 Participants
71.2 years
STANDARD_DEVIATION 7.28 • n=7 Participants
57.4 years
STANDARD_DEVIATION 9.24 • n=5 Participants
67.5 years
STANDARD_DEVIATION 10.82 • n=4 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
9 Participants
n=7 Participants
11 Participants
n=5 Participants
36 Participants
n=4 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
11 Participants
n=7 Participants
14 Participants
n=5 Participants
34 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Up to 90 minutes after investigational medicinal product (IMP) administration

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Participants With Probable Alzheimer's Disease
n=25 Participants
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
n=25 Participants
Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Abnormal (positive) participants by Reader A
23 Participants
0 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Normal (negative) participants by Reader A
2 Participants
25 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Abnormal (positive) participants by Reader B
23 Participants
0 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Normal (negative) participants by Reader B
2 Participants
25 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Abnormal (positive) participants by Reader C
23 Participants
0 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Normal (negative) participants by Reader C
2 Participants
25 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Abnormal (positive) participants by Reader D
23 Participants
0 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Normal (negative) participants by Reader D
2 Participants
25 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Abnormal (positive) participants by Reader E
23 Participants
1 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Normal (negative) participants by Reader E
2 Participants
24 Participants

PRIMARY outcome

Timeframe: Up to 90 minutes after IMP administration

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Participants With Probable Alzheimer's Disease
n=25 Participants
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
n=25 Participants
Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Abnormal (positive) participants by Reader F
23 Participants
0 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Normal (negative) participants by Reader F
2 Participants
25 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Abnormal (positive) participants by Reader G
22 Participants
1 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Normal (negative) participants by Reader G
3 Participants
24 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Abnormal (positive) participants by Reader H
23 Participants
0 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Normal (negative) participants by Reader H
2 Participants
25 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Abnormal (positive) participants by Reader I
23 Participants
1 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Normal (negative) participants by Reader I
2 Participants
24 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Abnormal (positive) participants by Reader J
23 Participants
1 Participants
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Normal (negative) participants by Reader J
2 Participants
24 Participants

Adverse Events

Participants With Probable Alzheimer's Disease

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Participants With Amnestic Mild Cognitive Impairment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy Volunteers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Sherwin, M.D., PhD

GE Healthcare

Phone: +1-774-843-3888

Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
  • Publication restrictions are in place

Restriction type: OTHER