A Comparative, Randomized, Open Label, Multicentric Clinical Trial of Memantine Hydrochloride Extended Release Tablets 28 mg Vs Memantine Hydrochloride tablets 10 mg in patients with Moderate to Severe Alzheimer Disease.
Phase 3
- Conditions
- Health Condition 1: null- Moderate to Severe Alzheimer DiseaseHealth Condition 2: G308- Other Alzheimers disease
- Registration Number
- CTRI/2010/091/001325
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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