None listed
Conditions
Interventions
Intervention1: Memantine IR: Patients who were already on Memantine IR for at least four weeks and who were on a stable dose of 10mg/day or 20mg/day will be enrolled and same dose will be continued fo
Sponsors
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluation of MMSE score between treatment groups 2.Evaluation of GDS score between treatment groups 3.Evaluation of global impression by investigator and patient between treatment groups. Timepoint: 1.Time points: Day 0, week 4, week 12 2.Time points: Day 0, week 4, week 12 3.Time points: Week 12 (end of treatment) | — |
Primary
| Measure | Time frame |
|---|---|
| Evaluation of ADAS-Cog score between treatment groups. Timepoint: Time points: Day 0, week 4, week 12 | — |
Countries
India
Contacts
Public ContactDr. Surendra Borgharkar
Outcome results
None listed