NCT03986424已完成3 期
Multi-center Open Comparative Randomized Study of Efficacy and Safety of Akatinol Memantine 20 mg (Single-doses) vs. Akatinol Memantine 10 mg (Double-doses) in Patients With Moderate and Moderately Severe Vascular Dementia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Change from baseline in total ADAS-cog score points
研究概览
简要总结
The study evaluates the clinical efficacy and safety of Akatinol Memantine 20 mg (single-doses) vs. Akatinol Memantine 10 mg (double-doses) in patients suffering from moderate and moderately severe vascular dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the patient or his/her legal representative if the patient is declared incapable by a court decision.
- •Understanding of study procedures and willingness to abide to all procedures during the course of the study by the patient or his/her legal representative.
- •Male and female patients from 50 to 85 years of age (inclusive) suffering from moderate and moderately severe vascular dementia.
- •Mini-Mental State Examination (MMSE) Test total scores of 10 to
- •Hachinski's Ischemic Score (HIS) of 7 or higher point.
- •Availability in the anamnesis of instrumental confirmation of the diagnosis (data methods of neurovisualization - CT or MRT).
- •For females: menopause or inability to conceive due to other reasons (hysterectomy, etc.).
- •Availability of a relative or legal representative who lives with the patient, monitors him/her and cares for the patient.
排除标准
- •Alzheimer's disease or secondary types of dementia.
- •Epilepsy, seizures, schizophrenia, other psychoses, bipolar disorder, alcoholism, drug abuse (including the history thereof).
- •Other clinically significant neurological or psychiatric disorders.
- •Severe depression (Hamilton score, HAM-D > 18 points).
- •Severe, unstable or decompensated physical disease (including clinically significant laboratory abnormalities) potentially affecting the trial findings.
- •Contraindications to oral drug intake during the time period determined by the study protocol.
- •Known hypersensitivity to the investigational product or any of its ingredients.
- •Administration of nootropic, anti-dementia and typical antipsychotic drugs, tricyclic antidepressants, long-acting benzodiazepines, NMDA receptor antagonists (amantadine, ketamine, dextromethorphan) for 1 month before the enrollment and during the study.
- •For females: pregnancy and breastfeeding.
- •Evidence or suspicion that the patient might not comply with the study directive.
- •Any reason or contraindication which in the investigator's opinion precludes participation in the study.
- •Patient is direct relative of an employee of the study site or Merz Pharma LLC.
- •Previous participation in this clinical study.
- •Participation in another clinical trial within the last 12 weeks prior to screening or ongoing participation in a study.
研究组 & 干预措施
Akatinol Memantine 20 mg
Experimental
Akatinol Memantine 20 mg once daily
干预措施: Akatinol Memantine 20 mg (Drug)
Akatinol Memantine 10 mg
Active Comparator
Akatinol Memantine 10 mg twice daily
干预措施: Akatinol Memantine 10 mg (Drug)
结局指标
主要结局
Change from baseline in total ADAS-cog score points
时间窗: 24 weeks
ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
终止
4 期
A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated AppendicitisAppendicitisNCT00236912Johnson & Johnson Pharmaceutical Research & Development, L.L.C.139
已完成
2 期
Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)HypertensionNCT00274716Merck Sharp & Dohme LLC249
已完成
2 期
Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus BacteremiaStaphylococcus Aureus BacteremiaStaphylococcus Aureus EndocarditisNCT03163446ContraFect121
已完成
1 期
Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy AdultsHealthy SubjectsNCT02476864Actelion12
终止
3 期
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir AloneHepatitis BNCT00376259Novartis43