Efficacy in Alzheimer's disease

Meta-analyses of six Phase III, placebo-controlled, 6-month studies in AD patients with MMSE <20 (memantine 29 mg/day, ITT (Intent To Treat), OC (Observed Cases)).

A meta analysis from six Phase III, placebo-controlled, 6-months studies showed that there was a statistically significant effect in favour of Ebixa (memantine) treatment for the cognitive, global, behavioural and functional domains (ref. 2).

Statistically significant effect of Ebixa in preventing marked clinical worsening (ref.3) ***p<0.001

Adapted graph: Pooled data from six 24/28-week placebo-controlled studies. Patients with AD and MMSE < 20 (memantine, n=797; placebo, n=678) and patients with MMSE 15-19 (memantine, n=261; placebo, n=209). Observed cases are presented.

Marked clinical worsening: decline of >= 4 points on ADAS-cog, or >=5 points on SIB, plus any deterioration on CIBIC-plus and ADCS-ADL

Statistically significantly fewer patients treated with Ebixa showed marked clinical worsening than patients receiving placebo, over the course of a 6-month treatment period (p<0.001)

• Ebixa halved the occurrence of marked clinical worsening compared to placebo for patients with MMSE <20 (Ebixa 10.8% vs placebo 21.1%; p<0.001)
• For patients with MMSE 15-19, Ebixa patients were three times less likely to progress than those receiving placebo (p=0.0003), suggesting that earlier treatment may be more beneficial

 

Ebixa combination therapy is statistically significantly superior to AChEI monotherapy (ref. 3, ref. 4)

Ebixa, in combination with an AChEI, slows the rate of decline in cognitive ability of patients with Alzheimer's disease. BDS, Blessed Dementia Scale (ref. 3, ref. 4).

Ebixa, in combination with an AChEI, slows the rate of decline in functional ability of patients with Alzheimer's disease (ref. 3, ref. 4).

• Ebixa combination treatment was superior to No treatment and AChEI monotherapy in slowing progression of cognitive and functional decline (ref. 4).
• These benefits had small-to-medium effect sizes that increased with time on treatment and were sustained for years (ref. 4).

 

 

References:

1.Ebixa SmPC

2. Winblad et al. Dement Geriatr Cogn Disord 2007; 24(1):20-27.

3. Wilkinson D. Int J Geriatr Psychiatry 2011; DOI: 10.1002/gps.2788

4. Atri A et al. Alzheimer Dis Assoc Disord 2008;22:209-221