E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
|
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 assess the efficacy of [18F]THK-5351 to detect Tau pathology in patients with AD, DS related dementia, nfPPA, bvFTD, PSP and CBD. |
Obtener información preliminar sobre la eficacia de [18F]THK-5351 en la detección de patología tau en la EA esporádica y asociada al SD, en la vcDFT, en los S-T4R así como en la nfaAPP. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety of [18F]THK-5351 in healthy subjects, as well as in patients with AD, DS related dementia, nfPPA, bvFTD, PSP and CBD. |
Evaluar la seguridad de [18F]THK-5351 en sujetos sanos, sujetos con EA esporádica, en la vcDFT, en los S-T4R, en la nfaAPP y en sujetos con síndrome de Down. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria for patients: (1) Men and women over eighteen years-old; (2) evaluated at the Memory unit of the Hospital de la Santa Creu i Sant Pau; (3) that meet current clinical criteria for Alzheimer disease dementia, mild cognitive impairment due to Alzheimer disease, DS related dementia, nfPPA, bvFTD, PSP and CBD; (4) and given written informed consent.
Inclusion criteria for healthy controls: (1) Men and women over eighteen years old; (2) currently enrolled in other clinical studies of the Memory unit at the Hospital de la Santa Creu i Sant Pau; (3) without cognitive complaints; (4) a normal performance on neuropsychological evaluation (adjusted by age and education); (5) and given written informed consent. |
Criterios de inclusión para los pacientes: (1) Hombres y mujeres de más de dieciocho años de edad; (2) evaluados en la unidad de memoria del Hospital de la Santa Creu i Sant Pau; (3) que cumplen con los criterios clínicos actuales para enfermedad de Alzheimer , deterioro cognitivo leve debido a la enfermedad de Alzheimer, demencia relacionada con la DS, nfPPA, bvFTD, PSP y el CDB; (4) consentimiento informado por escrito.
Los criterios de inclusión para los controles sanos: (1) Hombres y mujeres de más de dieciocho años de edad; (2) actualmente participando en otros estudios clínicos de la unidad de memoria en el Hospital de la Santa Creu i Sant Pau; (3) sin quejas cognitivas; (4) un desempeño normal en la evaluación neuropsicológica (ajustado por edad y educación); (5) consentimiento informado por escrito. |
|
E.4 | Principal exclusion criteria |
General exclusion criteria: (1) Non-compliance of inclusion criteria; (2) Diagnosis of major depression; (3) Previous stroke; (4) Inability to perform lumbar puncture, magnetic resonance imaging or neuropsychological evaluation. |
(1)No cumplir los criterios de inclusión (2) diagnóstico de depresión mayor (3) ictus previo (4) imposibilidad de realizar punción lumbar, RMN, o evaluación neuropsicológica. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Standarized uptake value ratios (SUVR) of generated images on PET-TC (Philips Gemini TF or en Philips Vereos Digital) during the first 90 minutes following the administration of [18F]THK-5351. |
Standardized uptake value ratios (SUVR) de las imágenes generadas con [18F]THK-5351 (0-90 min) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Adverse effects will be systematically evaluated and registered during the first 24 hours after the administration of the tracer. |
Aparición de acontecimientos adversos |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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
|
|
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 | 12 |
E.8.9.1 | In the Member State concerned days | |