| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | Dementia associated with Parkinson's disease | |
| 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 safety and tolerability (including an assessment of motor symptoms using the UPDRS) of open label 5-10 mg/day Aricept® in Parkinson's disease patients with dementia, who have completed the week 24 visit in the double-blind Aricept study E2020-E044-316. | |
| E.2.2 | Secondary objectives of the trial | To assess the efficacy of open label Aricept® (5-10mg/day) on cognitive and global clinical function in PD patients with dementia, assessed by the ADAS-cog scale, MMSE scale and CIBIC-plus scale respectively.
To assess the efficacy of open label Aricept® (5-10mg/day) on activities in daily living and behaviour.
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | a)Age range: patients must be aged 40 or over
b)Sex distribution: male and female
c)PD according to UK Brain Bank criteria40 with good response to levodopa as judged by investigator opinion.
d)Women of child bearing potential must have demonstrated a negative serum beta-HCG at the screening visit for the double-blind study (E2020-E044-316) and a negative urine test result at the screening visit for the open label extension study, (E2020-E044-318),
e)Completed all 24 treatment weeks of the double-blind study E2020-E044-316 and completed assessments.
f)Outpatients, with a responsible and reliable caregiver/study partner
g)Health: generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane); vision (glasses, contact lenses permissible), hearing (hearing aid permissible) and speech sufficient for compliance with testing procedures; must be capable of swallowing the study medication.
h)Written informed consent must be obtained from each patient and his/her caregiver/study partner prior to subjecting the patient or caregiver/study partner to any open label extension study related procedures.
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| E.4 | Principal exclusion criteria | a)Pregnant or lactating, women.
b)Women of childbearing potential unless (1) surgically sterile or (2) must be practicing effective contraception (e.g. abstinence, IUD or barrier method plus hormonal method). These patients must be willing to remain on current form of contraception for the duration of the study, (post menopausal women must be amenorrheic for at least 12 months to be considered of non-child bearing potential).
c)Patients with evidence of other psychiatric/neurological disorders, i.e., stroke, schizophrenia, seizure disorder, head injury with loss of consciousness (for at least 1 hour) within the past year, progressive supranuclear palsy, multisystem atrophy, or dementia complicated by other organic disease.
d)Evidence of clinically significant, active gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease. Evidence of second or third degree heart block. Patients with controlled hypertension (supine diastolic BP < 95 mmHg), right bundle branch block (complete or partial) and pacemakers may be included in the study.
e)Patients previously treated with centrally active AChE inhibitors (e.g., physostigmine, tacrine, metrifonate, galantamine, rivastigmine, donepezil) except the medication in the Aricept® double-blind study E2020-E044-316.
f)Patients and/or caregivers/study partners who are unwilling or unable to fulfil the requirements of the study.
g)Any condition which would make the patient or the caregiver/study partner, in the opinion of the investigator, unsuitable for the study.
h)Patients with known hypersensitivity to AChE inhibitors.
i)Patients who were non-compliant with the inclusion/exclusion criteria or with the study medication received in the preceeding Aricept® double-blind study E2020-E044-316.
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| E.5 End points |
| E.5.1 | Primary end point(s) | | There is no primary end point as this is an open label extension study. | |
| 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 | Yes |
| 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 | Information not present in EudraCT |
| 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) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Yes |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Information not present in EudraCT |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Information not present in EudraCT |
| E.8.1.5 | Parallel group | Information not present in EudraCT |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 | The trial involves single site in the Member State concerned | Information not present in EudraCT |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| 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 | Information not present in EudraCT |
| 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 | |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| 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 | | The end of the trial is when the last subject has received medication for 52 weeks and the scheduled assessments have been performed and documented. | |
| 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 | |
| E.8.9.2 | In all countries concerned by the trial months | 30 |
