NCT00371059已完成4 期
Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Cohen-Mansfield
研究概览
简要总结
We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks
详细描述
Agitation is a cause of morbidity and mortality in Alzheimer's due to distress and use of medication with side effects. Memantine has beed shown to be associated with less agitation and a recent study by forrest pharmaceuticals failed to recruit. We will perform a 12 week rct in 164 patients to test this hypothesis in a locality with no competing studies and in a clinical setting where the drug is not often used. We will compare with placebo and also use a rescue protocol derived from international best practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.
- •2. Alzheimer's Disease only as per McKhann Criteria + Hachinski Score\<=4.
- •3. Moderately severe to severe Alzheimer's Disease (baseline MMSE \ /=45.
- •6. Age \>/= 55.
排除标准
- •Memantine usage in the 4 weeks prior to the start of the study.
- •On Cholinesterase inhibitor for less than 3 months and not on a stable dose.
- •Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study.
- •Antiparkinsonian medication.
- •Hypersensitivity to memantine or any of the excipients in the formulation.
- •Severe renal impairment.
- •Epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment.
- •Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.
- •Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.
- •Severe, unstable or poorly controlled medical illness.
- •Any disability that may interfere with the patient completing the study procedure.
- •Active malignancy.
- •Delirium, pain or any medical illness as a clear cause of agitation.
- •Any important drug interactions: Prohibited during study and in the 14 days preceding enrollment/inclusion are: Analgesic dextromethorphan, Dopaminergics- amantadine, Warfarin due to theoretical INR prolongation.
结局指标
主要结局
Cohen-Mansfield
时间窗: 2 weeks
次要结局
- Neuropsychiatric Inventory 6+12 weeks(2 weeks)
- Clinical Global Impression 6+ 12 weeks(2 weeks)
- Severe Impairment Battery 6+12 weeks(2 weeks)
- Quality of Life 6+12 weeks(2 weeks)
- Co-meds(2 weeks)
- Incidents of agitation(2 weeks)
- Use of rescue protocol(2 weeks)
研究者
研究点 (2)
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