E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Parkinson's Disease |
Enfermedad de Parkinson |
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E.1.1.1 | Medical condition in easily understood language |
Parkinson's Disease |
Enfermedad de Parkinson |
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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 | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson'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 |
Assess safety of FBB PET Brain scan pre surgery in Parkinson diseade (PD) patients |
Evaluar la seguridad de PET cerebral prequirúsgico con florbetaben en pacientes con Enfermedad de Parkinson (EP) |
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E.2.2 | Secondary objectives of the trial |
Assess the proportion of FBB PET positive scans at baseline to the cut off in our reference population compare longitudinal changes in global, motor,cognitive and behavioural outcomes comparing progressing to dementia patients if any - comparing diferences in FBBPET between patients with worsening vs who doesn't |
Evaluar la proporción de PET con FBB positivos en basal con respecto a nuestra población de referencia -Comparar cambios en variables globales, motoras, cognitivas y de comportamiento en aquellos que progresan a demencia si los hubiera - comparar diferencias en PET con FBB entre pacientes que empeoran y aquellos que no |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. PD patients aged 60 to 69 years, 2. Motor fluctuations refractory to the best medical treatment that have led to the indication of STN-DBS; 3. Commitment to participate and complete all study procedures according to the principal investigator; 4. Voluntary fulfilment and signature of the study Informed Consent Form. |
1. Pacientes con EP entre 60 y 69 años, 2. Con fluctuaciones motoras resistentes al mejor tratamiento médico disponible que tienen indicada cirugía STN-DBS; 3. Pacientes comprometidos a participar y capaces de completar todos los procedimientos del estudio que le ha indicado el investigador principal; 4. Pacientes que otorgan consentimiento mediante la firma del formulario de Consentimiento informado |
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E.4 | Principal exclusion criteria |
1. Subjects not eligible for STN-DBS (due to presence of one or more exclusion criteria for STN-DBS including the possibility of a diagnosis different to PD, such as any of the atypical parkinsonisms) or likely not to be able to complete the study; 2. PD-related dementia according to the MDS definition of PD-dementia; 3. Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT ≥ 5 x ULN) or advanced renal insufficiency (creatinine ≥ 2 x ULN); 4. Current or previous history of alcohol abuse or epilepsy; 5. Allergy to FBB or any of its constituents; 6. Multiple drug allergies and/or previous history of contrast allergy; 7. Pregnancy or breast feeding or planned pregnancy during the study period; 8. Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function); 9. Evidence for any other neurological or psychiatric disease. |
1. Sujetos no elegibles para realización de cirugía STN-DBS (por uno o varios criterios que impidan la realización de cirugía STN-DBS incluyendo la posibilidad de un diagnóstico diferente de EP como alguno de los parkisonismos atípicos) o incapaces de completar el estudio; 2. Demencia relacionada con EP según definición de demencia en EP de la MDS ; 3. Cualquier Enfermedad relevante o historia de Enfermedad relevante, especialmente Enfermedad hepatobiliar (AST /ALT ≥ 5 x Límite superior de normalidad (ULN)) o insuficiencia renal avanzada (creatinina ≥ 2 x ULN); 4. Historia previa o actual de abuso de alcohol o epilepsia; 5. Alergia conocida a FBB o cualquiera de sus componentes; 6. Alergias multiples a medicamentos y/o alergia previa a contraste; 7. Embarazo o lactancia durante el estudio; 8. Cualquier enfermedad o historia de Enfermedad que, a criterio del investigador, pudiera alterar la function cerebral (ej déficit de Vitamina B12 o ácido fólico, función tiroidea alterada); 9. Evidencia de cualquier Enfermedad neurológica o psiquiátrica. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Incidence of adverse events of a single dose of FBB followed by PET scan in PD patients about to undergo DBS. - Proportion of + FBB PET scans at baseline - Proportion of patients with clinical important differences for each outcome measure including the proportion of patients progressing to dementia at 18 months (if any). |
- Incidencia de acontecimientos adversos (AA) tras una dosis única de FBB seguida de un scan PET en pacientes con EP un mes antes de intervención quirúrgica STN‐DBS; - Proporción de PET‐FBB positivos en la visita basal; - Proporción de pacientes con diferencias clinicamente relevantes en cada una de las variables de análisis incluyendo la proporción de pacientes que progresan a demencia a los 18 meses. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Significant correlations of longitudinal changes in motor, neuropsychological, and neuropsychiatric scores with SUVRs of baseline FBB-PET. 2. Significant differences in regional SUVR between PD patients experiencing motor, neuropsychological or neuropsychiatric worsening at follow-up and those remaining stable or getting better. 3. Cortical pattern of amyloid deposition in PD patients upon visual and quantitative examination |
1. Diferencias en el ratio del valor estándar de captación (SUVR) clínicamente relevante en las escalas motor (MDS‐UPDRS), cognitivo (PD‐CRS), o conductual (NPI) 2. Diferencias en el ratio del valor estándar de captación (SUVR) regional de FBB PET prequirúrgicos en pacientes con la enfermedad de Parkinson que experimentan empeoramiento clínico global relevante (CGI), motor (MDS‐UPDRS), cognitivo (PD‐CRS), o conductual (NPI) durante el seguimiento frente a los que no experimentan un cambio clínicamente relevante (es decir, se mantiene estable o mejorando); 2. La correlación de las variables motoras, cognitivas y conductuales de los SUVRs en FBB‐PET pre‐quirúrgico basalmente y a los 18 meses de seguimiento, así como su cambio longitudinal; 3. Patrón cortical de los depósitos de amiloide en pacientes con Parkinson según FBB PET (tanto mediante examen visual como semicuantitativo y por cuantificación). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.2.4 | 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 | 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 | 1 |
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 | 1 |
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 |