- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02813070
Comparison of PET Amyloid Imaging in Japanese and Western Subjects
May 3, 2017 updated by: GE Healthcare
An Open-label Study to Assess Brain Uptake and Safety of Flutemetamol F 18 Injection in Japanese Subjects With Probable Alzheimer's Disease, Subjects With Amnestic Mild Cognitive Impairment and Healthy Volunteers
This was a Phase 2, multicenter study to assess the extent and patterns of [18F] flutemetamol uptake in the brains of 3 groups of Japanese subjects: healthy volunteers (HV), amnestic mild cognitive impairment (aMCI), and probable Alzheimer's disease (pAD), and to assess the reproducibility of brain uptake and of image interpretation.
Subjects underwent open-label intravenous (i.v.) administration of Flutemetamol F 18 Injection and Positron emission tomography (PET) imaging of the brain.
Blinded visual image reads were performed by 10 independent board-certified readers (5 Japanese and 5 non-Japanese) with nuclear medicine image interpretation experience.
The blinded visual assessments were compared with the subject's clinical diagnoses, and the agreement between the image interpretations made by the 2 groups of readers (Japanese and non-Japanese) was determined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This was a Phase 2, multicenter study to assess the extent and patterns of [18F] flutemetamol uptake in the brains of 3 groups of Japanese subjects: HV, aMCI, and pAD, and to assess the reproducibility of brain uptake and of image interpretation.
The 3 comparison groups (HV, aMCI, and pAD) were defined by the subjects' main clinical diagnoses at study entry.
Subjects underwent diagnostic quality anatomic brain magnetic resonance imaging (MRI), followed by open-label intravenous (i.v) administration of Flutemetamol F 18 Injection and PET imaging of the brain.
Blinded visual image reads were performed by 10 independent board-certified readers (5 Japanese and 5 non-Japanese) with nuclear medicine image interpretation experience.
The blinded visual assessments were compared with the subject's clinical diagnoses, and the agreement between the image interpretations made by the 2 groups of readers (Japanese and non-Japanese) was determined.
Blinded visual assessments were also compared to quantitative image assessments (standardized uptake value ratio [SUVRs]).
Inter-reader and intra-reader agreement was also assessed.
Test-retest variability was evaluated following a second administration of Flutemetamol F 18 Injection given to a subset (N=5) of pAD subjects between 1 and 4 weeks after their first administration of Flutemetamol F 18 Injection.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
General inclusion criteria for all subjects:
- The subject had at least 6 years of education.
- The subject was of first-order Japanese descent.
- The subject exhibited adequate visual, auditory and communication capabilities, and was willing and able to complete standard tests of cognitive function.
- The subject's general health was adequate to comply with all study procedures, as ascertained by review of their medical history, and laboratory and physical examinations, which was performed within 45 days before the first administration of Flutemetamol F 18 Injection.
- The subject (and the caregiver, if relevant) was/were compliant and had a high probability of completing the study in the opinion of the investigator.
- Women were either surgically sterile (had a documented bilateral oophorectomy and/or documented hysterectomy) or were postmenopausal (cessation of menses for more than 2 years).
- Informed consent was signed and dated by the subject and/or subject's legally acceptable representative, if applicable, in accordance with local regulations.
Inclusion criteria specific for HV:
- The subject was 25 years or older at the time of obtaining informed consent.
- The subject had no evidence of cognitive impairment by medical history.
- The subject had a Mini-Mental State Examination (MMSE) score of =< 27.
- The subject had a Clinical Dementia Rating (CDR) of 0.
- The subject had an MRI image as part of the screening visit of sufficient diagnostic quality and consistent with normal brain function (details provided in the associated Imaging Manual) for volume of interest (VOI) definition and partial volume correction.
Inclusion criteria specific for subjects with pAD:
- The subject was 55 years or older at the time of obtaining informed consent.
- The subject met National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for clinical pAD and Diagnostic and Statistical Manual of Mental Disorders (DSM-IV]), 4th Edition, criteria for AD (DSM-IV criteria, American Psychiatric Association 1994).
- The subject had an MMSE score of 15 to 26 (inclusive) and a CDR of 0.5, 1 or 2.
- The subject had a score of =< 4 on the Modified Hachinski Ischemic scale.
- The subject had an appropriate caregiver capable of accompanying the subject on all study visits.
- The subject had an MRI image as part of the screening visit consistent with the diagnosis of pAD and of sufficient diagnostic quality (details provided in the associated Imaging Manual) for VOI definition and partial volume correction.
Inclusion criteria specific for subjects with aMCI:
- The subject was 55 years or older at the time of obtaining informed consent.
- The subject met Petersen criteria for aMCI.
- The subject had an MMSE score of 27 to 30 (inclusive) and a CDR of 0 to 0.5.
- The subject had a score of =< 4 on the Modified Hachinski Ischemic Scale.
- The subject had an appropriate caregiver/companion capable of accompanying the subject on all study visits if necessary and applicable according to local regulations.
- The subject had an MRI image as part of the screening visit consistent with the diagnosis of aMCI and of sufficient diagnostic quality (details provided in Imaging Manual) for VOI definition and partial volume correction.
Exclusion Criteria:
- The subject was not able to complete the study procedures as judged by the investigator.
- The subject had received ionizing radiation exposure of more than 1 mSv (except arising from head computed tomography [CT]) in the last 12 months or was determined unsuitable by the investigator as a result of radiation exposure in the past.
- The subject had a known or suspected hypersensitivity/allergy to [18F] flutemetamol or to any of its excipients.
- Female subjects who were of childbearing potential, pregnant, or nursing.
- The subject had a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records or reported medical history.
- The subject had a contraindication for MRI or PET (including, but not limited to, claustrophobia, pacemaker, the presence of metallic fragments, or cochlear implant).
- The subject had participated in a clinical trial using an investigational medicinal product (IMP) within 30 days of dosing.
- The subject had positive serology for HBs antigen, HCV antibody, HIV antibody or serologic test for syphilis.
- The subject regularly took medication with a known anticholinergic effect (which could have impaired memory) within the prior 3 months.
- The subject had a history of head injury associated with significant loss of consciousness that, in the opinion of the investigator, would have interfered with the interpretation of PET images.
Exclusion criteria specific for HV:
- The subject had any clinically significant medical or neurological condition or any clinically significant abnormality on physical, neurological or laboratory examination.
- The subject had a family history of pAD (more than 1 first degree relative with the diagnosis of pAD).
Exclusion criteria specific for subjects with pAD and aMCI:
- The subject had a significant neurological or psychiatric disorder (including, but not limited to, major depression, schizophrenia, mania, etc.) other than pAD that may have affected cognition.
- The subject had a previous history of clinically evident stroke or significant cerebrovascular disease on brain imaging.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy volunteers
185 MBq [18F] Flutemetamol
|
PET brain imaging and Magnetic resonance brain imaging
Other Names:
|
EXPERIMENTAL: Mild cognitive impairment
185 MBq [18F] Flutemetamol
|
PET brain imaging and Magnetic resonance brain imaging
Other Names:
|
EXPERIMENTAL: Alzheimer's Disease
185 MBq [18F] Flutemetamol
|
PET brain imaging and Magnetic resonance brain imaging
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers
Time Frame: Up to 90 minutes after investigational medicinal product (IMP) administration
|
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.
|
Up to 90 minutes after investigational medicinal product (IMP) administration
|
Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers
Time Frame: Up to 90 minutes after IMP administration
|
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.
|
Up to 90 minutes after IMP administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Levent Ture, GE Healthcare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
June 15, 2016
First Submitted That Met QC Criteria
June 22, 2016
First Posted (ESTIMATE)
June 24, 2016
Study Record Updates
Last Update Posted (ACTUAL)
June 5, 2017
Last Update Submitted That Met QC Criteria
May 3, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Cognition Disorders
- Alzheimer Disease
- Cognitive Dysfunction
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Flutemetamol
Other Study ID Numbers
- GE067-017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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