A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies

• Register: EUCTR
• Last refreshed on: 11 September 2012
• Main ID: EUCTR2005-002038-36-DE
• Date of registration: 19/01/2007
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies
• Scientific title: A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies
• Date of first enrolment: 29/11/2006
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002038-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, France, Germany, Greece, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Main 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 probable 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 equal to or less than III while “ON”
Female patient must be 2 years post-menopausal or surgically sterile
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:
Main 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
Patients with serum creatinine > 130mikromol/L in lab tests done at screening


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with Parkinson’s disease dementia or dementia with Lewy Bodies

Intervention(s)

Trade Name: Ebixa
Product Name: Memantine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Memantine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: N.A.

Main Objective: The objective of this study is to explore the efficacy and safety of memantine compared to placebo in out-patients with a diagnosis of PDD or DLB over a 6-month period

Primary end point(s): 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 testBehaviour – NPIGlobal – ADCS-CGICFunction – ADCS-ADLMotor function – UPDRS Caregiver burden – Zarit Burden interview

Secondary ID(s)

11018

N.A.

2005-002038-36-GR