E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Detection/Exclusion of cerebral ß-amyloid.
To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the BAY 94-9172 PET images compared to histological verification of the presence or absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truth. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001896 |
E.1.2 | Term | Alzheimer's disease |
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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 |
To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the BAY 94-9172 PET images compared to histological verification of the presence or absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truth. |
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E.2.2 | Secondary objectives of the trial |
To determine the sensitivity and specificity of the quantitative assessment of regional tracer uptake in BAY 94-9172 PET images compared to histological verification of the presence or absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truth.
To determine the sensitivity and specificity of the visual assessment of BAY 94-9172 PET images in detecting/excluding cerebral ß-amyloid in patients with dementia compared to non-demented healthy volunteers. The clinical diagnosis (if available) will serve as the reference standard.
To determine the sensitivity and specificity of the quantitative assessment of BAY 94-9172 PET images in detecting/excluding cerebral ß-amyloid in patients with dementia compared to non-demented healthy volunteers. The clinical diagnosis (if available) will serve as the reference standard.
To evaluate the safety and tolerability of a single dose of BAY 94-9172 (ZK 6013443). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects with a low probability of cerebral ß-amyloid deposition, e.g. non-demented volunteers and subjects with a high probability of ß-amyloid deposition, e.g.patients diagnosed with AD or Dementia with Lewy Bodies (DLB), 10 cognitively normal and young healthy volunteers between 21 and 40 years of age.
Each study participant has to meet the following criteria:
- is at least 21 years of age - females, no child-bearing potential of negative urine pregnancy test on day of BAY 94-9172 injection - exhibits visual, auditory, and communicative capabilities adequate to provide informed consent or assent and comply with study procedures - is willing and able to lie down in MRI and PET scanners - is willing to donate their brain for postmortem examination in case of death (not required of the healthy volunteers) - the subject or the subject and/or legally acceptable representative will be compliant and have a high probability of completing the study in the opinion of the investigator - has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability, as applicable, and informed consent or assent has been signed and dated by the subject and/or the subject's legally acceptable representative - |
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E.4 | Principal exclusion criteria |
Each subject who meets any of the following criteria must not participate in this study:
- has signs of major cerebrovascular disease as verified by medical history, e.g. fulfills the operational definitions of imaging guidelines of the NINDS-AIREN criteria for vascular dementia and by magnetic resonance brain imaging, e.g. an ARWMC score of > 2 - has any contraindication to magnetic resonance imaging examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan - is scheduled for surgery and/or another invasive procedure within the time period of up to 7 days following study drug administration - is allergic to the study drug or any of its constituents - has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to or a therapeutic radiopharmaceutical (e.g. 131I) within 10 days prior to the administration of the study drug or for whom administration of such substances is planned within 7 days following study drug administration - has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or was administered a radiopharmaceutical within 10 radioactive half-lives to study drug administration in this study - is medically unstable and whose clinical course during the observation period is unpredicatable as determined by the onsite investigator, e.g. patients/volunteers with acute myocardial infarction, stroke or renal failure. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The co-primary efficacy variables of the study will be the sensitivity and specificity of the visual assessment of regional tracer uptake in the BAY 94-9172 PET images in correctly differentiating between brain regions with and without ß-amyloid deposition. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
BAY94-9172: indicated for the detection of beta-amyloid in the brain compared to postmortem specimen |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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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For the end of this phase 3 study, the sponsor will closely survey the number of valid cases in each group of study participants. If the maximum number of valid patients in a specified group is enrolled, the investigators will immediately be informed to no longer enroll subjects within this group. |
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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 | 7 |
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 | 7 |