Dementia of Alzheimer’s Type [DAT] in patients with Mini Mental State Examination [MMSE]
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: In a second step functional communication, activities of daily living, global impression and tolerability will be assessed. ;Main Objective: The study objective is to evaluate the effects of memantine treatment on communication abilities and other cognitive abilities in moderate to severe DAT patients. Additionally tolerability data of the once daily intake of study medication will be collected and documented. The primary objective of the study is to show efficacy of the memantine once daily treatment on cognitive function and communication over a period of 12 weeks. ;Primary end point(s): To assess the efficacy of the memantine OD IR treatment using the Consortium to Establish a Registry for Alzheimer’s Disease [CERAD-NP] total score. The primary efficacy endpoint is the mean change in CERAD-NP total score from baseline to week 12 (end of treatment period). The single items of the CERAD-NP total score are: -1. Verbal Fluency -2. Modified Boston Naming Test [MBNT] -3. Word List Learning -4. Constructional Praxis -5. Word List Recall -6. Word List Recognition – Discriminability | — |
Countries
Austria, Germany
Outcome results
None listed