Dementia With Parkinson's Disease Clinical Trial
| Verified date | November 2005 |
| Source | Eisai Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | European Union: European Medicines Agency |
| Study type | Interventional |
A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | July 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Patients with an established diagnosis of PD and dementia, who fulfill all of the
inclusion criteria and none of the exclusion criteria listed below, will be eligible for
enrolment into this study. Best efforts must be made on clinical grounds to exclude patients with DLB and AD. The key inclusion criteria in this respect is the onset of dementia documented to have occurred at least 1 year after the diagnosis of PD. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Allgemeines Krankenhaus Barmbeck | Hamburg | Hambug |
| Germany | Parkinson Klinik Wolfach | Wolfach | |
| Ireland | Belfast City Hospital | Belfast | |
| Ireland | Unit 20 Black Poo Technology Centerl | Blackpool |
| Lead Sponsor | Collaborator |
|---|---|
| Eisai Limited |
Germany, Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PD patients with dementia will be screened up to 4 weeks prior to initiating dose administration. Baseline measurement on efficacy measures will be conducted at baseline, after which the first dose of study medication will be administered. |