E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10057167 |
E.1.2 | Term | Mental impairment disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The prinicpal goal of this study is to determine how accurate [18F]flutemetamol-PET scanning is at identifying amyloid pathology in the living brain. This will be achieved by determining the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem brain tissue samples. |
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E.2.2 | Secondary objectives of the trial |
(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. (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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 judgement 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 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 the Flutemetamol (18F) Injection administration) must be negative. |
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E.4 | Principal 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 signing consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary analysis will be to determine the level of association of the PET measurements with the immunohistochemical estimates of amyloid level across the 25 regions of interest (ROIs) within a subject as well as across subjects. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Patient enrollment may be stopped when sufficient data have been collected based on feedback from regulatory authorities. If the study is stopped early, a standard brain post-mortem to confirm prior diagnosis may be performed instead of the post-mortem detailed in the Pathology Manual. All remaining tissue will be given to the brain bank for future studies. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |