Study of the efficacy and safety of memantine in patients with Parkinson?s disease dementia or dementia with Lewy Bodies

• Conditions: Parkinson?s disease dementia or dementia with Lewy Bodies; MedDRA version: 14.1Level: PTClassification code 10067889Term: Dementia with Lewy bodiesSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2005-002038-36-ES
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-15
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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 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 between I to 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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
;
? 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 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 between I to 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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified