EUCTR2005-005087-93-GB进行中（未招募）1 期
A randomized double blind placebo controlled trial of Memantine in the treatment of Agitation in Alzheimers Dementia - MAGD trail (Memantine for Agitation in Dementia)
East Kent Hospitals NHS Trust0 个研究点目标入组 164 人开始时间: 2006年9月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 164
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
入选标准
- •1. Residential/Inpatients at recruitment with a history of at least 2 weeks behavioural disturbance
- •2. Alzheimer’s Disease only as per NINCDS-ADRDA Criteria (McKhann et al 1984) + Haschinski Score<=4.
- •3. Moderately severe to severe Alzheimer’s Disease (as determined by baseline MMSE < 19).
- •4. Clinically significant agitation that requires pharmacological or non pharmacological treatment.
- •5. Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) = 45 (Cohen Mansfield 1995).
- •6. Age > 45.
- •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
- •1.Memantine usage in the 4 weeks prior to the start of the study.
- •2. On Cholinesterase inhibitor for less than 3 months and not on a stable dose.
- •3. Anti-psychotic, benzodiazepine or hypnotic dosage alteration in the week prior to the start of the study.
- •4. Antiparkinsonian medication
- •5. Hypersensitivity to memantine or any of the excipients in the formulation.
- •6. Severe renal impairment.
- •7. Epilepsy or history of convulsions or receiving antiepileptic medication.
- •8. Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.
- •9. Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.
- •10. Severe, unstable or poorly controlled acute or chronic medical illness.
- •11. Any disability that may interfere with the patient completing the study procedure.
- •12. Active malignancy.
- •13. Any medical illness as a clear cause of agitation, including Delirium + pain.
- •14. Any important drug interactions: Prohibited during study and in the 14 days preceding enrollment/inclusion are: Analgesic dextromethorpan, Dopaminergics- amantadine. Warfarin due to INR prolongation.
- •During the study patients will be allowed to continue taking stable doses of concomitant medicines including antidepressants, antihypertensives, anti-inflammatory drugs, atypical anti-psychotics, anticoagulants, laxatives, diuretics, hypnotics and benzodiazepines (Tariot et al, 2004). Concomitant administration of anti-parkinsonian medication will be permitted but stable dose and no patients on amantadine this is to avoid difficulties with PD stability as Memantine can have benefit in PD. Cholinesterase inhibitors will not be permitted unless patients have been stable on that medication for at least 3 months.
研究者
相似试验
已完成
4 期
Study of controlled release mebeverine in irritable bowel syndrome in comparison to placebo.CTRI/2018/03/012897Department of Pharmacology40
已完成
不适用
A study to assess the effects of GutGard in the management of Helicobacter pyloriCTRI/2011/08/001968ICS CO LTD100
已完成
不适用
A comparative clinical trial to study the effect of Herbal Supplements- NRCC-01 & NRCC-02 in pre-diabetic subjects.CTRI/2011/05/001729atural Remedies Pvt Ltd150
进行中（未招募）
不适用
A randomized double blind placebo controlled trial of intranasal submucosal bevacizumab in hereditary hemorrhagic telangiectasia - Bevazizumab in HHTepistaxisEUCTR2009-018049-19-ATMedizinische Universität Wien,Univ.Klinik f.Hals-, Nasen- und Ohrenkrankheiten30
已完成
4 期
clinical trial azithromycin versus doxycycline chemoprophylaxis in leptospirosis in farmersleptospirosis.A27.8,A27.9IRCT2015052322383N1Vice Chancellor for Research, Mazandaran University of Medical Sciences270