Prospective, single-arm, multi-center, open-label study to investigate the efficacy and tolerability of the once daily [OD] memantine treatment

• Conditions: Dementia of Alzheimer’s Type [DAT] in patients with Mini Mental State Examination [MMSE] < 20; MedDRA version: 10.0Level: LLTClassification code 10012271Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2006-003616-21-DE
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

- Signed informed consent prior to the initiation of any study specific procedures
- Male or female outpatient at least 50 years of age and at least 8 years of education
- Patient has German as mother-tongue or at least speaks the language fluently
- Patient has a current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria and with DSM IV TR criteria for Dementia of the Alzheimer’s type
- Communication difficulties, which are judged by a physician to be closely related to the diagnosis of Alzheimer’s disease
- Alzheimer’s disease confirmed by Magnet Resonance Imaging [MRI], or Computer Tomography [CT] scan within the past 12 months before study entry or MRI conducted at screening
- Patient’s MMSE total score is less than 20
- Patient has a knowledgeable and reliable carer who will accompany the patient to all clinic visits during the course of the study
- Patient’s concomitant treatment is in accordance to Study Protocol 9.4.7.1 and Appendix A
- If female, the patient is at least 2 years post menopausal or surgically sterile
- Patient’s sight and hearing is sufficient to undertake the study-related procedures and psychometric tests without difficulty
- The Investigator believes that the patient will be capable of completing all study-related psychometric tests during the study
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

- Patient with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease
- Patient has a recent history (within 3 months prior to screening), or currently untreated, B12, thyroidea stimulating hormone [TSH] or folate deficiency, which is considered clinically significant
- Patient with evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer’s disease
- Patient has a Modified Hachinski Ischemia score greater than 4 at screening
- Patient with current evidence of clinically significant, unstable psychiatric illness (other than symptoms associated with Alzheimer’s disease) including, psychotic disorders and bipolar or unipolar depression
- Patient has an oncological diagnosis (hematological or solid tumor) which is currently being treated or there is still evidence of active disease
- Patient has a history of severe drug allergy, hypersensitivity, or known hypersensitivity to amantadine and lactose
- Patient has a known or suspected history of alcoholism or drug abuse within the past 10 years
- Patient has participated in an investigational drug study, or has received treatment with an investigational drug within 90 days (or 5 half-lives, whichever is longer) prior to the screening visit
- Patient has been previously treated with memantine or has participated in an investigational study of memantine
- Patient has any disease or treatment which according to the investigator’s judgment, could interfere with the assessments of safety, tolerability or efficacy
- Patient, or patient with her/his carer, are unwilling, or unable to abide by the visit schedule and other study requirements
- Patient has any type of evident aphasia, which may interfere with patient’s communication difficulties caused by Alzheimer’s disease

Study & Design

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