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 - ND

• Conditions: MedDRA version: 8.1Level: LLTClassification code 10012267Term: Dementia; Patients with Parkinson s disease dementia PDD and patients with dementia with Lewy Bodies DLB

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-04
• 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) no
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
;
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) no
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

Any patient who meets one or more of the following criteria cannot be included in the study 1. Patients with evidence of any neurodegenerative disease other than PDD/DLB or other serious neurological disorders including, but not limited to Alzheimer s disease, frontotemporal dementia, vascular dementia probable or possible according to NINDS-AIREN criteria ; Huntington s disease, Progressive Supra nuclear Palsy, Multiple System Atrophy, Cortico Basal Degeneration, major cortical stroke or history of repeated strokes with stepwise progression of parkinsonian features, major or repeated head trauma, primary or secondary cerebral neoplasia, cerebral infection and normal pressure hydrocephalus. 2. Patients with a recent history of within 3 months of screening or currently untreated B12 or folate deficiency, which is considered clinically significant. 3. Patients with history of brain surgery or history of/current deep brain stimulation. 4. Patients with history of exposure to toxins or other drugs e.g. dopamine antagonists , which could account for the symptoms of parkinsonism. 5. Patients with a current diagnosis according to DSM-IV-TR of amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, or post-traumatic stress disorder. Patients may be included if symptoms of major depression are treated and have been stable for 3 months . 6. Patients with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease that could interfere with the study results. Patients with controlled diabetes, or patients with controlled hypertension, or right bundle branch block complete or partial may be included in the study. Patients with thyroid disease may also be included in the study, provided they are euthyroid. . 7. Patients with a systolic blood pressure while sitting greater than 180 mm/Hg, or less than 90 mm/Hg, or a diastolic blood pressure while sitting greater than 100 mm/Hg, or less than 50 mm/Hg at the Screening or Baseline visits. 8. Patients with history of seizures or known predisposing factors for epilepsy. 9. Patients with a history of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine, rimantidine or lactose. 10. Patients with an active oncological disease haematological or solid tumour within 5 years. Patients with local dermatological tumours such as basal or squamous cell carcinoma may be included if stable. 11. Patients with a known or suspected history within the past 5 years of alcoholism or drug abuse. 12. Patients who have taken AChEIs within 6 weeks prior to screening. AChEIs are not allowed during the course of the study. 13. Patients who are currently receiving memantine, or have taken memantine within the last 6 months prior to screening. 14. Patients who are taking, or have taken, any disallowed concomitant medications as defined in Appendix II that cannot be discontinued or switched to a permissible alternative, according to the timelines provided in Appendix II. 15. Patients who have been in an investigational drug study, or who have received treatment with an investigational drug within 30 days or 5 half-lives, whichever is longer of the screening visit. 16. The patient or caregiver, in the opinion of the investigator, is unlikely to comply with the clinical study;
Any patient who meets one or more of the following criteria cannot be included in the study 1. Patients with evidence of any neurodegenerative disease other than PDD/DLB or other serious neurological disorders including, but not limited to Alzheimer s disease, frontotemporal dementia, vascular dementia probable or possible according to NINDS-AIREN criteria ; Huntington s disease, Progressive Supra nuclear Palsy, Multiple System Atrophy, Cortico Basal Degeneration, major cortical stroke or history of repeated strokes with stepwise progression of parkinsonian features, major or repeated head trauma, primary or secondary cerebral neoplasia, cerebral infection and normal pressure hydrocephalus. 2. Patients with a recent history of within 3 months of screening or currently untreated B12 or folate deficiency, which is considered clinically significant. 3. Patients with history of brain surgery or history of/current deep brain stimulation. 4. Patients with history of exposure to toxins or other drugs e.g. dopamine antagonists , which could account for the symptoms of parkinsonism. 5. Patients with a current diagnosis according to DSM-IV-TR of amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, or post-traumatic stress disorder. Patients may be included if symptoms of major depression are treated and have been stable for 3 months . 6. Patients with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease that could interfere with the study results. Patients with controlled diabetes, or patients with controlled hypertension, or right bundle branch block complete or partial may be included in the study. Patients with thyroid disease may also be included in the study, provided they are euthyroid. . 7. Patients with a systolic blood pressure while sitting greater than 180 mm/Hg, or less than 90 mm/Hg, or a diastolic blood pressure while sitting greater than 100 mm/Hg, or less than 50 mm/Hg at the Screening or Baseline visits. 8. Patients with history of seizures or known predisposing factors for epilepsy. 9. Patients with a history of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine, rimantidine or lactose. 10. Patients with an active oncological disease haematological or solid tumour within 5 years. Patients with local dermatological tumours such as basal or squamous cell carcinoma may be included if stable. 11. Patients with a known or suspected history within the past 5 years of alcoholism or drug abuse. 12. Patients who have taken AChEIs within 6 weeks prior to screening. AChEIs are not allowed during the course of the study. 13. Patients who are currently receiving memantine, or have taken memantine within the last 6 months prior to screening. 14. Patients who are taking, or have taken, any disallowed concomitant medications as defined in Appendix II that cannot be discontinued or switched to a permissible alternative, according to the timelines provided in Appendix II. 15. Patients who have been in an investigational drug study, or who have received treatment with an investigational drug within 30 days or 5 half-lives, whichever is longer of the screening visit. 16. The patient or caregiver, in the opinion of the investigator, is unlikely to comply with the clinical study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to explore the efficacy and safety of memantine compared to placebo in outpatients with a diagnosis of PDD or DLB over a 6-month period;Secondary Objective: none;Primary end point(s): No primary endpoint will be defined. All analyses will be exploratory.;Main Objective: The objective of this study is to explore the efficacy and safety of memantine compared to placebo in outpatients with a diagnosis of PDD or DLB over a 6-month period;Secondary Objective: none;Primary end point(s): No primary endpoint will be defined. All analyses will be exploratory.