E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dementia of Alzheimer’s Type [DAT] in patients with Mini Mental State Examination [MMSE] < 20 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 10.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012271 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
In a second step functional communication, activities of daily living, global impression and tolerability will be assessed.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 23 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |