E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer's Disease (AD), preclincal stages of AD |
ziekte van Alzheimer, preklinische stadia van de ziekte van Alzheimer |
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E.1.1.1 | Medical condition in easily understood language |
dementia, Alzheimer's disease, preclinical stage |
dementie, ziekte van Alzheimer, voorstadia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012271 |
E.1.2 | Term | Dementia Alzheimer's type |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10001897 |
E.1.2 | Term | Alzheimer's disease (incl subtypes) |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001896 |
E.1.2 | Term | Alzheimer's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10074616 |
E.1.2 | Term | Prodromal Alzheimer's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system 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 |
To explore the natural time course of specific [18F]AV-1451 binding in patients with subjective cognitive decline after two and four year follow up a. To compare rate of change in [18F]AV-1451 binding according to baseline amyloid status b. To compare rate of change in [18F]AV-1451 binding according to clinical progression over time
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Het onderzoeken van het natuurlijke tijdsbeloop van [18F]AV-1451 bij patiënten met subjectieve geheugenklachten na twee en vier jaar follow-up a. Het vergelijken van de mate van verandering van [18F]AV-1451 binding en baseline amyloid status b. Het vergelijken van de mate van verandering van [18F]AV-1451 binding en progressie van het klinisch beeld
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E.2.2 | Secondary objectives of the trial |
1. To investigate the relationship between tau pathology, as measured with [18F]AV-1451, and amyloid load, as measured with [18F]Florbetapir 2. To investigate the correlation between [18F]AV-1451 binding and neuropsychological performance 3. To investigate the correlation between [18F]AV-1451 binding and grey matter volume on MRI 4. To investigate the correlation between [18F]AV-1451 binding and CSF measures of amyloid-beta 1-42, total tau and phosphorylated tau
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1. Het onderzoeken van de relatie tussen tau pathologie, gemeten met [18F]AV-1451 en amyloid status, gemeten met [18F]Florbetapir. 2. Het onderzoeken van de relatie tussen [18F]AV-1451 binding en neuropsychologische 3. Het onderzoeken van de correlatie tussen [18F]AV-1451 binding en volume van grijze stof op MRI 4. Het onderzoeken van de correlatie tussen [18F]AV-1451 binding and CSF amyloid-beta 1-42, total tau and phosphorylated tau
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Clinically diagnosed with 'subjective cognitive decline' after the standardized dementia screening performed at the VUmc Alzheimer Center - At least 50 years of age - Enrollment in the FIAD cohort (protocol nr 13-256) - Have received or will receive a [18F]Florbetapir PET scan 90 days before or after the [18F]AV-1451 PET scan |
- Klinische diagnose 'subjectieve geheugenklachten', na de gestandardiseerde dementie-screening in het VUmc Alzheimercentrum - Tenminste 50 jaar oud - Deelname aan de FIAD studie (protocol nr 13-256) - Binnen 90 dagen voor of na de [18F]Florbetapir PET-scan kan een [18F]AV-1451 PET-scan worden verricht |
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E.4 | Principal exclusion criteria |
- Has contraindications for MRI scanning and therefore can not receive brain MRI - Has evidence for structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of PET scan - Is a woman of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods for contraception. Women of childbearing potential must not be pregnant or breast feeding at screening. - 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.; - Has ever participated in an experimental study with a tau targeting agent, unless it can be documented that the subject received only placebo during the course of the trial; - Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv - Has a history of severe traumatic brain injury (TBI)
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- Contra-indicaties voor een MRI-scan, en kan daardoor geen MRI-scan ontvangen - Aanwijzingen voor structurele afwijkingen op de MRI, zoals een herseninfarct of ruimte-innemend proces, waardoor interpretatie van de PET-scan bemoeilijkt wordt - Potentieel vruchtbare vrouwen, niet chirurgisch gesteriliseerd, die zich niet onthouden van seksuele activiteit of geen gebruik maken van betrouwbare anticonceptie. Potentieel vruchtbare vrouwen mogen niet zwanger zijn of borstvoeding geven. - Voorgeschiedenis met ernstige medicijnenallergie of hypersensitiviteit - Voorgaand radiofarmacon toegediend gekregen binnen 6 halfwaardetijden OF wanneer de totale jaarlijkse stralingsdosis meer dan 10 mSv is - Eerder deelgenomen aan een experimentele studie met een tau of amyloid targeting agent, behalve als kan worden aangetoond dat patiënt alleen placebo kreeg toegediend - Voorgeschiedenis van ernstig traumatisch hersenletsel (traumatic brain injury, TBI)
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in [18F]AV-1451 binding over time |
Het verschil van [18F]AV-1451 binding in de tijd |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Continuous PET scan from 0-60 and 80-130 minutes post injection. Repeat after 2 and 4 years. |
Continue PET-scan van 0-60 en van 80-130 minuten na injectie. Herhaling na 2 en 4 jaar. |
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E.5.2 | Secondary end point(s) |
Relation between [18F]AV-1451 binding and neuropsychological tests, grey matter atrophy on MRI and CSF measures |
Relatie tussen [18F]AV-1451 binding en neuropsychologische tests, grijze stof atrofie op MRI en CSF waarden |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At baseline and after 2 and 4 years follow up |
Baseline en na 2 en 4 jaar follow-up |
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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 | Yes |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |