E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Neurodegenerative conditions characterized by the cerebral accumulation of the protein tau |
Enfermedades neurodegenerativas caracterizadas por la acumulación cerebral de proteína tau |
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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 |
- To obtain preliminary information on the efficacy of 18F-PI-2620 in the detection of tau pathology in AD associated with SD - To evaluate the safety of 18F-PI-2620 in healthy subjects, subjects with SD. |
- Obtener información preliminar sobre la eficacia de 18F-PI-2620 en la detección de patología tau en la EA asociada al SD - Evaluar la seguridad de 18F-PI-2620 en sujetos sanos, sujetos con SD. |
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E.2.2 | Secondary objectives of the trial |
To correlate the uptake of 18F-PI-2620 with: - Cognitive and functional scales. - Measures of cerebral atrophy in MRI. - Tau and phosphorylated tau levels in the cerebrospinal fluid. |
Correlacionar la captación de 18F-PI-2620 con: - Las escalas cognitivas y funcionales. - Medidas de atrofia cerebral en la RM. - Los niveles de tau y tau fosforilada en el líquido cefalorraquídeo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Criteria of control subjects: - Men and women with age> 35 years. - Absence of cognitive complaints. - Normal neuropsychological examination with MMSE scores between 24 and 30, absence of subjective memory complaints or objective memory deficit (measured with the Free and Cued Selective Reminding Test - FCSRT- (Grober, Buschke et al. 1988)) with a scalar score equal to or greater than 8 and a clinical dementia rating scale (CDR) score of 0 (Morris 1993). - Understand and accept the study procedures and sign an informed consent (guardian and / or patient).
Inclusion criteria for participants with DS: - Men and women diagnosed with DS> 35 years. - Intellectual quotient> 34 (equivalent to mild and moderate mental retardation according to ICD-10 criteria). - Existence of reliable informant. - Participants / legal guardians who sign the IC for inclusion in the study. |
Criterios de sujetos controles: - Hombres y mujeres con edad > 35 años. - Ausencia de quejas cognitivas. - Normalidad de la exploración neuropsicológica con puntuaciones en el MMSE entre 24 y 30, ausencia de quejas subjetivas de memoria o déficit objetivo de memoria (medido con el Free and Cued Selective Reminding Test - FCSRT- (Grober, Buschke et al. 1988)) con una puntuación escalar igual o mayor a 8 y una puntuación en el clinical dementia rating scale (CDR) de 0 (Morris 1993). - Comprender y aceptar los procedimientos del estudio y firmar un consentimiento informado (tutor y/o paciente).
Criterios de inclusión para participantes con SD: - Hombres y mujeres diagnosticados de SD > de 35 años. - Cociente intelectual > 34 (equivalente a retraso mental leve y moderado según criterios del CIE-10). - Existencia de informador fiable. - Participantes/ tutores legales que firmen el CI para inclusión en el estudio. |
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E.4 | Principal exclusion criteria |
- Not meeting the inclusion criteria. - Severe depression (Geriatric scale score Scale depression> 20). - History of stroke, Hachinski score> 4 or previous neurological or psychiatric illness. - Confirmed pregnancy or possibility of pregnancy at the time of inclusion in the study. |
- No cumplir los criterios de inclusión. - Depresión grave (puntuación escala Geriatric Depresión Scale>20). - Historia de ictus, puntuación de Hachinski >4 o enfermedad neurológica o psiquiátrica previas. - Embarazo confirmado o posibilidad de embarazo en el momento de la inclusión en el estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Standardized uptake value ratio (SUVR) of images generated with 18F-PI-2620 (images measured between 0-90 min of administration will be obtained; SUVR images of 18F-PI-2620 will be corrected to the RM using the software SPM8. The cerebellum will be used as the reference region), as a measure of tau protein aggregates in the brain.
- Presence of adverse effects within 24 hours after administration. |
- Standardized uptake value ratios (SUVR) de las imágenes generadas con 18F-PI-2620 (se obtendrán imágenes medidas entre 0-90 min de la administración; las imágenes SUVR del 18F-PI-2620 serán corregistradas a la RM usando el software SPM8. Se usará el cerebelo como región de referencia), como medida de agregados de proteína tau en el cerebro.
- Presencia de efectos adversos durante las 24 horas posteriores a la administración. |
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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) |
- Correlation of SUVR with the clinical variables (CAMDEX-DS, CAMCOG) that will be obtained from the patient's medical history. - Correlation with measures of cerebral atrophy measured by FreeSurfer in MR (cortical thickness). - Correlation with the measures of tau and phosphorylated tau in CSF. |
- Correlación de SUVR con las variables clínicas (CAMDEX-DS, CAMCOG) que se obtendrán de la historia clínica del paciente. - Correlación con las medidas de atrofia cerebral medidas mediante FreeSurfer en RM (grosor cortical). - Correlación con las medidas de tau y tau fosforilada en LCR. |
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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 | Yes |
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) | 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.8.2.4 | 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 | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |