Health Condition 1: null- Moderate to Severe Alzheimer Disease Health Condition 2: G308- Other Alzheimers disease
Conditions
Interventions
Intervention1: Memantine Hydrochloride Extended Release Tablets: Once daily for 24 weeks.
Control Intervention1: Memantine Hydrochloride Tablets: Twice daily for 24 weeks.
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Have a diagnosis of Alzheimer disease 2.Have an MMSC score more than or equal to 3 OR less than or equal to 14 at screening 3.Must be able to swallow tablets 4.Must have caregiver to attent the study visit
Exclusion criteria
Exclusion criteria: 1.Patients less than 45 & more than 65 years. 2.History of hypersensitivity to the study drug or similar class of drugs. 3.Patients who have taken memantine within one month of Screening 4.Patients who, in the clinicians judgement, are likely to be placed in a nursing home within the next 6 months. 5.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination (MMSE)Timepoint: Day 1, 6th week, 12th week, 18th week and 24th week;Mini-Mental State Examination (MMSE)Timepoint: Day 1, 6th week, 12th week, 18th week and 24th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life - Alzheimer's Disease (QOL-AD) ScaleTimepoint: Day 1, 6th week,12th week,18th week and 24th week;safety of the drugTimepoint: Day 1, 6th week,12th week,18th week and 24th week | — |
Countries
India
Contacts
Public ContactDrShailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed