E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Parkinson?s disease dementia or dementia with Lewy Bodies |
Demencia en pacientes con enfermedad de Parkinson o de demencia en pacientes con cuerpos de Lewy |
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E.1.1.1 | Medical condition in easily understood language |
Parkinson?s disease dementia or dementia with Lewy Bodies |
Demencia en pacientes con enfermedad de Parkinson o de demencia en pacientes con cuerpos de Lewy |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067889 |
E.1.2 | Term | Dementia with Lewy bodies |
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 | 14.1 |
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.1.3 | 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 efficacy and safety of memantine compared to placebo in outpatients with a diagnosis of PDD or DLB over a 6-month period |
Explorar la eficacia y seguridad de memantina comparado con placebo en pacientes ambulatorios con diagnóstico de demencia con enfermedad de Parkinson o demencia con cuerpos de Lewy |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Male or female, out-patients of at least 50 years of age ? Written informed consent must be obtained from the patient (or a legally acceptable representative if applicable and if different from the responsible caregiver) and the responsible caregiver ? The patient has a current diagnosis of Parkinson?s disease according to the clinical diagnostic criteria of the United Kingdom Parkinson?s Disease Society Brain Bank and a current diagnosis of Parkinson?s disease Dementia according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (code 294.1) or the patient has a current diagnosis of DLB according to the third report of the DLB consortium ? Mini Mental State Examination total score between 10 and 24 (both inclusive) ? Modified Hoehn & Yahr score is between I to III inclusive while ?ON? ? Female patient must be 2 years post-menopausal or surgically sterile |
? Pacientes ambulatorios de ambos sexos con una edad mínima de 50 años ? Se obtendrá el consentimiento informado por escrito del paciente (o representante legalmente aceptable en los casos necesarios, y si es diferente al cuidador responsable) y cuidador responsable ? Los pacientes tienen diagnóstico actual de enfermedad de Parkinson de acuerdo con los criterios diagnósticos de la United Kingdom Parkinson?s Disease Society Brain Bank, y un diagnóstico actual de demencia con enfermedad de Parkinson de acuerdo con la cuarta edición de Diagnostic and Statistical Manual of Mental Disorders (código 294.1) o el paciente tiene diagnóstico actual de demencia con cuerpos de Lewy (DLB) de acuerdo con el tercer informe del consorcio DLB ? Puntuación total Mini Mental State Examination entre 10 y 24 (ambos inclusive) ? Puntuación Modificada Hoehn & Yahr de I a III inclusive durante la fase ?ON? ? En el caso de que el paciente sea mujer se requiere al menos un periodo de 2 años de postmenopausia o esterilidad por cirugía |
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E.4 | Principal exclusion criteria |
? Patients with diagnosis of any other neurodegenerative disease other than PDD or DLB ? Patients who have taken AChEIs within 6 weeks prior to screening. (AChEIs are not allowed during the course of the study) ? Clinically significant physical illness ? History (within the last 10 years) of alcoholism or drug abuse ? Patients who have taken memantine in the past 6 months ? Use of disallowed concomitant medication |
? Pacientes con diagnóstico de otra enfermedad neurodegenerativa además de PDD o DLB ? Pacientes que han recibido AChEI en las 6 semanas previas a la selección (no se permiten los AChEI durante el estudio) ? Enfermedades físicas clínicamente significativas ? Antecedentes (en los últimos 10 años) de alcoholismo o abuso de sustancias ? Pacientes que han recibido memantina en los últimos 6 meses ? Uso de medicación concomitante prohibida |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessments ? Criteria for Evaluation ? Efficacy: Cognition ? Verbal fluency test, Brief Extended Verbal Paired Associates test, Trails Making Test, Simple and choice reaction time, Cogstate Set shifting test, Adas-cog Orientation test, Digit ordering test, Verbal Recall and Recognition Test, Boston Naming test, Benton facial Recognition test, Benton Judgement of Line Orientation test, Ten-point clock drawing test, the Stroop interference test Behaviour ? NPI Global ? ADCS-CGIC Function ? ADCS-ADL Motor function ? UPDRS Caregiver burden ? Zarit Burden interview
Assessments ? Criteria for Evaluation ? Safety: AEs and vital signs |
Valoraciones ? Criterios de evaluación ? Eficacia: Cognitivas ? Verbal fluency test, Brief Extended Verbal Paired Associates test, Trails Making Test, Simple and choice reaction time, Cogstate Set shifting test, Adas-cog Orientation test, Digit ordering test, Verbal Recall and Recognition Test, Boston Naming test, Benton facial Recognition test, Benton Judgement of Line Orientation test, Ten-point clock drawing test, Stroop interference test Conducta ? NPI Global ? ADCS-CGIC Función ? ADCS-ADL Función motora ? UPDRS Carga para el cuidador ? Zarit Burden interview
Valoraciones ? Criterios de evaluación ? Seguridad: Acontecimientos adversos (AA) y constantes vitales |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Screening/End of Weeks -2 to ?1: Visit 1 Baseline/End of Weeks 0: Visit 2 Treatment/End of Weeks 4 12 16: Visits 3, 4, 5 Period Completion/withdrawal Follow -up/End of Weeks 24: Visit 6 |
Screening/Fin de las semanas-2 a ?1: Visita 1 Basal/Fin de la semana 0: Visita 2 Tratamiento/Fina de la semana 4 12 16: Visitas 3, 4, 5 Periodo Finalización/Retirada y seguimiento/Fin de la semana 24: Visita 6 |
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E.5.2 | Secondary end point(s) |
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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 | 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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
France |
Germany |
Greece |
Spain |
Turkey |
United Kingdom |
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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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Last Patient Last Visit per protocol |
Último paciente última visita por protocolo |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 23 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 23 |
E.8.9.2 | In all countries concerned by the trial days | 0 |