E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cognitively healthy elderly, aged 60-100 years old. |
Gezonde ouderen zonder cognitieve problemen, tussen 60-100 jaar. |
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E.1.1.1 | Medical condition in easily understood language |
Healthy elderly without memory problems, aged 60-100. |
Gezonde ouderen zonder geheugenproblemen, tussen 60-10 jar. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
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 |
1. To investigate the effect of amyloid status (positive versus negative) on [18F]AV-1451 binding in cognitively normal individuals. 2. To investigate the contribution of genetic factors and non-genetic factors to tau accumulation and its interaction with amyloid accumulation. |
1. Onderzoek naar het effect van de amyloïdstatus (positief versus negatief) op [18F] AV-1451-binding bij cognitief normale individuen. 2. Onderzoek naar de bijdrage van genetische factoren en niet-genetische factoren aan tau stapeling en de interactie ervan met amyloïd stapeling. |
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E.2.2 | Secondary objectives of the trial |
1. To investigate the relation of [18F]AV-1451 binding with other AD-markers: -Neuropsychological performance -Grey matter volume on MRI -CSF measures of total tau, phosphorylated tau and amyloid-β 1-42 and β 1-40 2.To investigate the relation of tau accumulation with AD risk factors collected in the PreclinAD study (2014.210): -Age -Education -APOE genotype
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1. Om de relatie van [18F] AV-1451-binding met andere AD-markers te onderzoeken: -Neuropsychologische testen -Grijze stof volume op MRI -CSF-metingen van totale tau, gefosforyleerde tau en amyloïde-β 1-42 en β 1-40 2. Om de relatie tussen tau-accumulatie en AD-risicofactoren te onderzoeken verzameld in de PreclinAD-studie (2014.210): -Leeftijd -Opleiding -APOE-genotype |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion in PreclinAD study (2014.210) and a subject must be older than 60 years and have received an [18F]flutemetamol amyloid PET scan and/or have a known amyloid status obtained from CSF.
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Inclusie in PreclinAD-onderzoek (2014.210) en een proefpersoon moet ouder dan 60 jaar zijn, een [18F] flutemetamol-amyloïde PET-scan hebben ondergaan en / of een bekende amyloïd status verkregen uit CSF (liquor) |
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E.4 | Principal exclusion criteria |
1.Has contra indications for MRI scanning and therefore has not received brain MRI; 2.Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of PET scan; 4.Has a relevant history of severe drug allergy or hypersensitivity. Relevant severe drug allergies should be determined by the Principal Investigator or Co-Principal Investigator, and any questions about a subject’s eligibility can be directed to Avid Radiopharmaceuticals Inc.; 5.Has ever participated in an experimental study with a tau agent, unless it can be documented that the subject received only placebo during the course of the trial; 6.Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives or when total yearly radiation exposure exceeds 16.1 mSv for female and 22.4 mSv for male participants[25]. 7.Has a history of severe traumatic brain injury (TBI).
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1. Contra-indicaties voor MRI-scanning en kan daarom geen MRI voor hersenen ontvangen; 2. heeft aanwijzingen voor structurele afwijkingen zoals ernstig herseninfarct of ruimte-innemend proces die waarschijnlijk de interpretatie van PET-scan zal verstoren; 4. Heeft een relevante geschiedenis van ernstige medicijnallergie of overgevoeligheid. Relevante ernstige medicijnallergieën moeten worden bepaald door de hoofdonderzoeker of co-principal investigator en vragen over de geschiktheid van een onderwerp kunnen worden gericht aan Avid Radiopharmaceuticals Inc .; 5. Eerder deelgenomen aan een experimenteel onderzoek met een tau-middel, tenzij kan worden aangetoond dat de proefpersoon in de loop van het onderzoek alleen een placebo heeft gekregen; 6. Voorgaand radiofarmacon toegediend gekregen binnen 6 halfwaardetijden of wanneer de totale jaarlijkse blootstelling aan straling hoger is dan 16,1 mSv voor vrouwen en 22,4 mSv voor mannelijke deelnemers. 7. Heeft een voorgeschiedenis van ernstig traumatisch hersenletsel (TBI). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Quantitative assessment of tau accumulation, as measured with [18F]AV-1451. |
de kwantitatieve beoordeling van tau stapeling, gemeten met [18F] AV-1451 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
continous PET scan from 0-30 and 80-100 minutes post injection at baseline |
continu PET scan van 0-30 en 80-100 minuten na injectie op baseline |
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E.5.2 | Secondary end point(s) |
.- Amyloid status, based on the quantitative assessment of amyloid load, as measured with [18F]Flutemetamol or CSF amyloid; - Neuropsychological performance, grey matter volume on MRI, CSF tau and amyloid concentrations; - AD risk factors: age, APOE genotype and education.
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- Amyloïd status, gebaseerd op de kwantitatieve beoordeling van amyloïd stapeling, gemeten met [18F] Flutemetamol of CSF-amyloïd; - Neuropsychologische onderzoeken, volume van grijze stof op MRI, CSF tau en amyloïde concentraties; - AD-risicofactoren: leeftijd, APOE-genotype en opleiding. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
continous PET scan from 0-30 and 80-100 minutes post injection at baseline |
continu PET scanvan 0-30 en 80-100 minuten na injectie op baseline |
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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 | No |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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 | No |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |