Patients with Parkinson’s disease dementia or dementia with Lewy Bodies
Conditions
Interventions
Trade Name: Ebixa
Product Name: Ebixa
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion 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 probabl 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 inclusive 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 ;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 probabl 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 inclusive 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
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 > 130µmol/L in lab tests done at screening Patients unable to complete five or more of the baseline cognitive tests. ;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 > 130µmol/L in lab tests done at screening Patients unable to complete five or more of the baseline cognitive tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;Secondary Objective: N.A.;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;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;Secondary Objective: N.A.;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 | — |
Countries
Austria, France, Germany, Greece, Italy, Spain, United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed