Healthy volunteers (the absence of brain amyloid will be studied
Conditions
Interventions
Product Name: Flutemetamol (18F) Injection
Product Code: AH110690 (F18) Injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F] flutemetamol
CAS Number: 765922-62-1
Concentrat
Sponsors
GE Healthcare Ltd. and its Affiliates
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The subject is an >18 and 28, and considered to be cognitively normal per Investigator's judgment. (4) The subject has MRI scan as part of the screening visit of sufficient diagnostic quality and consistent with normal brain function. (5) The subject had at least 6 years of education or has a good work history (sufficient to exclude mental retardation). (6) The subject’s general health is adequate to comply with study procedures, as ascertained by review of their medical history, and laboratory and physical examinations, which must have been performed within 45 days before administration of Flutemetamol (18F) Injection. (7) For women who are either surgically sterile (have had a documented bilateral oophorectomy and/or documented hysterectomy) or are postmenopausal (cessation of menses for more than 3 years), enrollment in the study without a pregnancy test at screening will be allowed. For women of childbearing potential, the results of a serum and urine human chorionic gonadotropin pregnancy test (with the result known on the day of and before IMP administration) must be negative. (8) Informed consent is signed and dated by the subject in accordance with local regulations. (9) The subject is willing and able to participate in all study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT) or participated in any other clinical study within 30 days of study entry. (2) The subject has known allergies to Flutemetamol (18F) Injection or to any of the constituents. (3) The subject is pregnant or breast-feeding. (4) The subject has a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records. (5) The subject has a contraindication for MRI (including, but not limited to, claustrophobia, pacemaker, and presence of metallic fragments near the eyes or spinal cord, or cochlear implant). (6) The subject has a history of head injury with loss of consciousness. (7) The subject has any clinically significant medical, psychiatric or neurological condition or any clinically significant abnormality on physical, neurological or laboratory examination that might be associated with brain pathology, as determined by the Investigator. (8) The subject has a family history of AD (more than 1 first degree relative [i.e. birth parents and siblings] with diagnosis of AD). (9) The subject is undergoing monitoring of occupational ionizing radiation exposure. (10) The subject has a history of HIV infection or hepatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the overall specificity of Flutemetamol (18F) Injection for excluding the presence of brain amyloid based on the visual assessment of a PET scan by independent blinded readers reviewing images from a population of healthy young adult subjects aged 18 to 40.;Secondary Objective: (1) To characterize the safety ascribed to a single dose of Flutemetamol (18F) Injection. (2) To determine the composite standard uptake value ratio (SUVR) following Flutemetamol (18F) Injection in a population of healthy young adults. (3) To determine the composite SUVR following Flutemetamol (18F) Injection by individual demographic parameter, clinical site and geographic location, and the commonly used scanners used to obtain the images in this study (4) To determine the specificity of Flutemetamol (18F) Injection for excluding the presence of brain amyloid based on the visual assessment of a PET scan by independent blinded readers for individual demographic parameters, PET scanning time (10 minutes vs. 30 minutes), clinical site and geographic location, and the commonly used scanners used to obtain the images in this study. ;Primary end point(s): The primary endpoint will be the visual assessment of the individual PET images classified as normal or abnormal for the presence of amyloid based on independent blinded reads using 3 blinded independent readers. | — |
Countries
Finland, United Kingdom
Outcome results
None listed