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 oud. |
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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 60-100 jaar. |
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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 |
The main objectives are to identify markers for amyloid pathology in cognitively normal subjects, to identify risk factors for amyloid pathology in cognitively normal subjects and to identify predictors for cognitive decline in cognitively normal subjects with amyloid pathology. |
De belangrijkste doelstellingen van dit onderzoek zijn om markers voor amyloïdpathologie te identificeren in ouderen zonder cognitieve problemen, om risicofactoren te vinden voor amyloïdpathologie in ouderen zonder cognitieve problemen en om voorspellers te identificeren voor cognitieve achteruitgang in ouderen zonder cognitieve problemen met amyloid pathologie. |
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E.2.2 | Secondary objectives of the trial |
Secondary objective are to determine the concordance of amyloid and other AD markers in monozygotic twins, to investigate the overlap between amyloid pathology as assessed in CSF and assessed on PET scan and to create a substantial control group of elderly without amyloid. |
Secundaire doelstellingen zijn om de concordantie van amyloid en andere AD-markers in eeneiige tweelingen te bepalen, om de overlap tussen amyloidpathologie te onderzoeken, zoals die bepaald is in de liquor en op de PET-scan en om een substantiële controlegroep te creëren van ouderen zonder amyloid.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 60-100 years - Monozygotic twin - Telephone Interview for Cognitive Status modified (TICSm) >22 - Geriatric Depression Scale (GDS) (15 item) <11 - Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) 10 word list immediate and delayed recall (> -1.5 SD of age adjusted normative data) - Clinical Dementia Rating (CDR) scale of 0 with a score on the memory subdomain of 0 |
- Leeftijd 60-100 jaar - Monozygote tweeling - Telephone Interview for Cognitive Status modified (TICSm) >22 - Geriatric Depression Scale (GDS) (15 item) <11 - Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) 10 woorden lijst directe en vertraagde herinnering (> -1.5 SD op leeftijd gecorrigeerde normatieve data) - Clinical Dementia Rating (CDR) score van 0 met een score op het geheugen subdomein van 0 |
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E.4 | Principal exclusion criteria |
- clinical diagnosis of probable Alzheimer's disease or mild cognitive impairment - neurological problems like Parkinson's disease, Huntington disease, severe head trauma, braintumour, stroke with physical impairment, epilepsy currently using antiepileptic drugs, braininfection - known uncontrolled diabetes, thyroid disease, vitamin B12 deficiency - psychiatric disorder like psychosis or schizophrenia |
- klinische diagnose Alzheimer of mild cognitive impairment - neurologische ziekten zoals m. Parkinson, m. Huntington, ernstig hoofdtrauma, hersentumoren, stroke met lichamelijke beperkingen, epilepsie met gebruik van antiepileptica, herseninfectie. - bekende ongecontroleerde diabetes, schildklierproblemen, vitamine B12 deficientie - ernstige psychiatrische stoornis zoals psychosen of schizofrenie |
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E.5 End points |
E.5.1 | Primary end point(s) |
Main outcome measure at baseline is the presence of amyloid pathology assessed by CSF analysis or PET scan. The main outcome at follow-up is cognitive performance after 2 years. |
De belangrijkste uitkomstmaat bij aanvang van de studie is de aanwezigheid van amyloidstapeling op basis van PET- of liquordiagnostiek. De belangrijkste uitkomstmaat bij follow-up na 2 jaar is de cognitieve prestatie. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of baseline data will be executed after the last subject's visit at baseline, evaluation of follow-up data will be executed after last subject's visit at follow-up. |
Evaluatie van baseline data wordt uitgevoerd na het laatste baseline bezoek van de laatste proefpersoon, evaluatie van follow-up data wordt uitgevoerd na het laatste vervolgbezoek van proefpersoon. |
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E.5.2 | Secondary end point(s) |
Secondary endpoints are to determine the concordance of amyloid and other AD markers in monozygotic twins and to investigate the overlap between amyloid pathology as assessed in CSF and assessed on PET scan. And to assess differences in cognitive performance between subjects with and without amyloid. |
Secundaire doelen zijn om de concordantie van amyloid en andere AD-markers in eeneiige tweelingen te bepalen en om de overlap tussen amyloidpathologie te onderzoeken, zoals die bepaald is in de liquor en op de PET-scan. En om eventuele verschillen in cognitie te zien tussen personen met en zonder amyloid.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of baseline data will be executed after the last subject's visit at baseline. |
Evaluatie van baseline data wordt uitgevoerd na het laatste baseline bezoek van de laatste proefpersoon. |
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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) | 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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
longitudinale observationele studie |
longitudinal observatory |
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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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 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 | 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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The end of the study is defined as the last patient's last visit. |
Het eind van de studie is gedefinieerd als het laatste bezoek van de laatste patient. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |