Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations.

Conditions: patients with advanced (>5 years) Parkinson's disease and visual hallucinations.
MedDRA version: 9.1Level: LLTClassification code 10047570Term: Visual hallucinations
MedDRA version: 9.1Level: LLTClassification code 10013113Term: Disease Parkinson's

Registration Number: EUCTR2008-006278-13-NL

Lead Sponsor: MCG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 10

Inclusion Criteria

10 patients with advanced PD (>5 years) and visual hallucinations
PD according to the UK Brain Bank Criteria
At least weekly visual hallucinations
Patients must be able to understand the procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unstable internal disease
Major depression
MMSE<24
Use of the following medication: anticholinergics, amantadine, selegiline (washout at least 2 weeks), tricyclic antidepressants (washout al least 1 month), cholinesterase inhibitors

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if a stable optimal dose of galantamine can prevent an increase or emergence of VH after increase of L-dopa therapy. ;Secondary Objective: Secondly, the effect of galantamine on cognition and mood will be investigated.;Primary end point(s): Severity of VH after an increase of the L-dopa dose, combined with galantamine vs. an increase without galantamine as measured by the UM-PDHQ (percentage change on the UM-PDHQ).

Secondary Outcome Measures