Clinical Studies

Several large clinical trials have evaluated the effectiveness and safety profile of memantine in the treatment of moderate to severe Alzheimer's disease. Some of the key studies are:

- The MEM-MD-02 Study: This 24-week study compared memantine 20 mg/day to placebo in nursing home residents with severe Alzheimer's disease. Results showed memantine significantly improved behavioral symptoms and cognitive functions compared to placebo.

- The MEM-MD-12 Study: A 28-week trial compared memantine 20 mg/day to placebo in outpatients with moderate to severe disease. Memantine treated patients experienced significantly less deterioration in activities of daily living skills and global function compared to placebo.

- The MEM-MD-04 Study: A 24-week study evaluated memantine 28 mg/day compared to placebo in patients with moderate to severe disease. Memantine treated group showed significant benefits on measures of cognition, behavior, and ability to perform daily activities.

Based on the efficacy demonstrated in these clinical trials, the FDA approved memantine for treatment of moderate to severe Alzheimer's disease. The drug provides consistent benefits on cognition, functionality, behavior and global function.

Memantine Dosage and Administration

If approved by a medical practitioner, Memantine comes as oral tablets that are taken once or twice daily. The recommended starting dose of memantine is 5 mg taken once daily. This is then increased gradually over 4 weeks to achieve the target maintenance dose of 10 mg twice daily. The time of day does not affect efficacy, so tablets can be taken with or without food. For patients with severe renal impairment, the dose needs adjustment based on creatinine clearance rates. Close medical monitoring is required to check for side effects and response to treatment while on memantine therapy.

Safety and Tolerability

Overall, memantine has been found to be well-tolerated in clinical studies involving Alzheimer's patients. Common side effects reported include dizziness, headache and constipation. These are usually mild to moderate in severity. Serious side effects like hallucinations and confusion have occurred in a small percentage of people during memantine use. As with any medication, risks may be higher in the elderly population with multiple comorbid conditions. Therefore, doctors should carefully weigh risks versus benefits when prescribing memantine, especially in very advanced stages of Alzheimer's disease. Proper dosage titration helps minimize potential adverse reactions.

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