EUCTR2007-004489-41-DE进行中（未招募）不适用
Prospective, single-arm, multi-center, open-label study to investigate the potential to reduce concomitant antipsychotics use in subjects with moderate dementia of Alzheimer’s type [DAT] treated with memantine - MemAP
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Current diagnosis of probable AD consistent with NINCDS-ADRDA criteria and with DSM IV TR criteria for DAT (precised in Appendices B and C)
- •- Treatment with typical or atypical antipsychotic medication for at least 5 days/week during the last 3 months prior to the screening visit
- •- If DAT treated with a cholinesterase inhibitor, treatment with a stable dose during the 3 months preceding the screening visit
- •- MMSE score of 10-19 / GDS score of 3-5
- •- Signed informed consent prior to the initiation of any study specific procedures
- •- Male or female of age = 50 years and <85 years
- •- The subject speaks German as a mother tongue or at least speaks German fluently in order to comply with the study requirements
- •- MRI or CT scan supporting the diagnosis of DAT without indications of any relevant other CNS disorders
- •- Sufficient sight and hearing (a hearing aid is permitted) to enable the performance of study-related procedures and psychometric tests
- •- In the investigator’s opinion, the subject will be capable of completing all study-related activities
- •- If female, subject is at least 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previous or current treatment with memantine or participation in an investigational study with memantine
- •- Treatment with depot antipsychotics
- •- Treatment with more than 2 antipsychotic drugs at the time of study entry and during 3 months prior to the screening visit
- •- Intake of any medication that is contra-indicated in combination with memantine (precised in SmPC)
- •- Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease (Note, subjects with controlled diabetes and hypertension can be included, provided they do not use unauthorized concomitant medication)
- •- Within 3 months prior to screening clinically significant or currently untreated B12, TSH or folate deficiency (subjects with thyroid disease can be included in the study, provided they are stable and euthyroid)
- •- History of severe drug allergy, or hypersensitivity, or known hypersensitivity to amantadine and lactose
- •- Evidence (including CT/MRI results) of any clinically significant CNS disease other than AD, especially other types of dementia (e.g. vascular type dementia, Lewy-body disease, etc.)
- •- Modified Hachinski Ischemia score > 4 at screening (precised in Appendix D)
- •- Current evidence of clinically significant unstable psychiatric illness (other than symptoms associated with AD) including bipolar or unipolar depression
- •- Lifetime diagnosis of psychotic disorder other than symptoms associated with AD
- •- Cancerous disease (hematological or solid tumor), which is currently under treatment or evidence of active disease
- •- Known or suspected history of alcoholism or drug abuse within the past 2 years
- •- Participation in another clinical study for an investigational medicinal product within the previous 90 days (or 5 half-lives of the investigational medicinal product, whichever is longer) prior to the screening visit or during the study
- •- Any disease or medical treatment that can interfere with the assessment of safety, tolerability or efficacy, according to the investigator’s judgment
研究者
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