The subjects have a short life expectancy. GE-067-007 will determine the level of association between brain uptake of (18F)flutemetamol and brain amyloid levels. Assessments will be based on analysis of PET images and the quantitative immunohistochemical estimates of levels of amyloid as determined from post-mortem analysis of corresponding brain tissue samples. MedDRA version: 12.1 Level: LLT Classification code 10048669 Term: Terminal state
Conditions
Sponsors
GE Healthcare Ltd. and its Affiliates
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator. (2) The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia. (3) Informed consent has been signed and dated by the subject and/or the subject’s legally acceptable representative if applicable, in accordance with local regulations. (4) The subject has a caregiver who is reliable and will ensure that the subject complies with the protocol, if necessary in the judgment of the Investigator. (5) The subject’s general health is adequate to undergo the study procedures. (6) 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 2 years), enrollment in the study without a pregnancy test at screening is 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 the Flutemetamol (18F) Injection administration) must be negative. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) The subject has known or suspected structural brain abnormalities, such as infarcts or tumors, that may interfere with the interpretation of PET images. (2) The subject has a contraindication for PET. (3) The subject is pregnant or lactating. (4) The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients. (5) The subject is unable to tolerate or cooperate with study procedures. (6) The subject has participated in any clinical study using an investigational agent within 30 days of dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol (from analysis of positron emission tomography [PET] images) and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.;Secondary Objective: (1) To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol (from analysis of PET images) and quantitative histochemical regional estimates of brain levels of amyloid from post-mortem analysis of corresponding brain tissue samples. The quantitative estimates of brain uptake of [18F]flutemetamol SUVR will be the same estimates defined for the primary objective. (2) To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol (from analysis of PET images) and quantitative biochemical (enzyme-linked immunosorbent assay [ELISA]) regional estimates of brain levels of amyloid from post-mortem analysis of corresponding brain tissue samples.;Primary end point(s): The primary endpoint will be the region-specific estimates of cortical tracer uptake determined from quantitative analysis of the [18F]flutemetamol PET images. The quantitative estimate will be the SUVR. Regions of interest (ROI) selected for estimation of [18F]flutemetamol uptake will correspond to the 1 cm3 cubes of tissue taken for amyloid analysis. There will be up to 25 such regions analyzed per brain hemisphere. The number and location of these regions were chosen to provide samples representative of the entire cortex. The uptake estimates for the primary endpoint will be determined for the ROI from the left hemisphere of the brain. | — |
Countries
Belgium, Finland, United Kingdom
Outcome results
None listed