Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer

Study Overview
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Brief Summary
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Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.

Official Title
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Interventional, Randomised, Double-blind, Study to Evaluate the Safety and Tolerability of Once Daily Versus Twice Daily Memantine Treatment in Patients With Dementia of Alzheimer's Type and MMSE Range 5 - 18

Conditions
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Alzheimer Dementia (AD)

Intervention / Treatment
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* Drug: Memantine (once daily)
* Drug: Memantine (twice daily)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study. The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening Exclusion Criteria: The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm. The patient has a modified Hachinski ischemia score greater than 4 at the screening visit. The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor Other protocol defined inclusion and exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memantine (once daily)<br>Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally | Drug: Memantine (once daily)<br> <br> * Other names: Ebix ®;|
| Experimental: Memantine (twice daily)<br>Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally | Drug: Memantine (twice daily)<br> <br> * Other names: Ebix ®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of patients who reported adverse events | baseline to week 16 (end of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADCS - CGIC Score at Week 12 | The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a semi-structured interview designed to assess clinically relevant changes in patients with Alzheimer's disease. Items in the ADCS-CGIC interview provide general information, and information about cognition, behaviour, social and daily functioning. Responses to ADCS-CGIC interview result in a global clinical judgement of severity (at baseline) and clinically relevant change at subsequent visits. Severity rated at baseline is only used for reference. The severity at baseline is rated on a 7-point Likert-type scale from 1(normal, not ill at all) to 7 (among the most extremely ill patients). The ADCS-CGIC relevant change is rated on a 7-point Likert-type scale from 1 (marked improvement) to 7 (marked worsening). | ADCS - CGIC score at Week 12 |