Evaluation of efficacy and safety of Memantine ER versus Memantine IR in the treatment of moderate to severe Alzheimer?s disease: an open label, switch-over, comparative, multi-centric study.

Sun Pharmaceutical Industries Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Male or Female patients aged between 50 to 80 years.
•2.Patients who met criteria for Alzheimer?s type dementia as described in the DSM-IV, fourth edition and criteria for probable Alzheimer?s disease according to the National Institute of Neurological and Communicative disorders and stroke and Alzheimer?s disease and Related Disorders Association will be enrolled for the study.
•3.Patients already taking Memantine IR for at least four weeks before screening.
•4.Patients willing to give consent for participation in the study.

•1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
•2.Patients with hypersensitivity to Memantine.
•3.Patients who showed an evidence of any cause for their dementia other than AD.
•4.Patients with epilepsy.
•5.Patients with renal impairment
•6.Patients with hepatic impairment.
•7.Patients with concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or dextromethorphan.
•8.Patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension.
•9.Patients with concomitant use of cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine.
•10.Patients with severe and unstable cardiac disease.
•11.Patients with severe obstructive pulmonary disease or asthma or haematological disorder.
•12.Patients with other life threatening condition (such as rapidly progressing malignancies).
•13.Patients with a known or suspected history of drug or alcohol misuse in the prior 10 years.
•14.Patients taking health food supplements containing acetylcholine precursors, putative memory enhancers, insulin, and psychotropic drugs.
•15.Patients with concomitant diseases such as hypertension, non-insulin dependent diabetes, and arthritis.
•16.Patients taking small doses of short-acting benzodiazepines, chloral hydrate, or haloperidol.

发起方