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36 Interventions in Alzheimer’s Disease KCE Reports 111 Excellence (NICE); 2006. Clinical Guideline 42. Hansen RA, Gartlehner G, Lohr KN, Kaufer DI. Functional outcomes of drug treatment in Alzheimer's disease: A systematic review and meta-analysis. Drugs Aging. 2007;24(2):155-67. McShane R, Areosa Sastre A, Minakaran N. Memantine for dementia. Cochrane Database Syst Rev. 2006(2):CD003154. Birks J. Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database Syst Rev. 2006(1):CD005593. A. P. A. Work Group on Alzheimer's Disease and other Dementias, Rabins PV, Blacker D, Rovner BW, Rummans T, Schneider LS, et al. American Psychiatric Association practice guideline for the treatment of patients with Alzheimer's disease and other dementias. Second edition. Am J Psychiatry. 2007;164(12 Suppl):5-56. SBU. Dementia – Diagnostic and Therapeutic Interventions. A systematic review. Volume 2. June 2008. Loveman E, Green C, Kirby J, Takeda A, Picot J, Payne E, et al. The clinical and cost-effectiveness of donepezil, rivastigmine, galantamine and memantine for Alzheimer's disease. Health Technol Assess. 2006;10(1):iii-iv, ix-xi, 1-160. NICE, 2006. Kirby J, Green C, Loveman E, Clegg A, Picot J, Takeda A, et al. A systematic review of the clinical and cost-effectiveness of memantine in patients with moderately severe to severe Alzheimer's disease. Drugs Aging. 2006;23(3):227- 40. 4.3 REVIEWS OF ALZHEIMER DISEASE MEDICATION December 2005 July 2005 June 2005 2004 July 2004 July 2004 July 2004 For the medicines considered, large randomized, double-blind, placebo-controlled phase 3 trials were conducted resulting in regulatory approval. Most of these studies were funded by the pharmaceutical industry. In a few studies the comparator was another ChEI. No trials were identified comparing ChEIs versus other medications or nonpharmaceutical interventions. With the exception of three donepezil trials and a small size Exelon trial, the treatment duration did not exceed 6 months. 68 The patients were diagnosed as AD according to at least one of the following criteria: NINCDS-ADRDA, ICD-10 and DSM-III, DSM-III-R or DSM-IV. In the more recent trials on mild to moderate dementia the criteria also stated that CT or MRI should be consistent with the diagnosis of AD, and a modified Hachinski ischemic score
KCE Reports 111 Interventions in Alzheimer’s Disease 37 Indication in Belgium Institutionalization prevention Global clinical impression Cognition improvement at 6 months ADL improvement Table 5. Difference with the placebo group for AD medications Donepezil Galantamine Rivastigmine 5 - 10 mg/d 16 – 24 mg/d 6 – 12 mg/d Mild to moderately severe dementia No interpretable data 69 7 point CIBIC+ Significant improvement 69 Improved: 21-26% vs 11-14% on placebo; improved or stable: 57-75% vs 49-55% 14 mean change -0.45 (-0.54 to - 0.36) 70 70 point ADAS-cog: about 2 points improvement 69 - 2.02 (-2.77 to - 1.26) for 5 mg; -2.92 (-3.74 to – 2.10) for 10 mg 14 -2.83 (-3.29 to - 2.37) 70 No interpretable data, effect (minor) can be assumed 69 Mild to moderately severe dementia No interpretable data 69 7 point CIBIC+ Significant improvement 69 improved: not significant; % patients stable or improved (66% vs 52%): significant in the three studies 14 RR improved or stable 1.22 (1.12 to 1.33) 70 70 point ADAS-cog: about 3 points improvement 69 -3.1 (-4.1 to -2.1) for 16 mg; -3.3 (-3.9 to - 2.7) for 24 mg 14 - 2.46 (-3.47 to - 1.44)* 70 About 3 points on DAD (minor effect) 69 Mild to moderately severe dementia No interpretable data 69 7 point CIBIC+ Significant improvement 69 improved: significant (37% vs 20%) in one of the four studies; endpoint stable or improved not stated 14 mean change -0.36 (-0.45 to - 0.27) 70 70 point ADAS-cog: about 3 point improvement 69 -2.09 (-2.65 to -1.54) for 6 to 12 mg 14 -3.91 (-5.48 to - 2.34)* 70 About 3 points on PDS (minor effect) 69 Memantine 20 mg/d in moderately severe to severe AD (monotherapy) Moderate to severe dementia No interpretable data; indications that data were collected but not made public 19 7 point CIBIC+ No indications for improvement based on available data 19 Mean change of borderline significance 14 -0.28 (-0.41 to -0.15) 71 -0.27 (-0.43 to -0.10) 70 100 point SIB Results not clear, not robust, heterogeneous 19 7 points on SIB but not significant for MMSE 14 4.46 (1.87 to 7.04)* 70 2.97 (1.68 to 4.26) 71 ADCS-ADL Patient QoL No effect 69 No data 69 No data 69 No data 19 Caregiver QoL No effect can be inferred from Indications for a minor positive effect No relevant data found 69 1.39 (0.39 to 2.39)** 70 1.27 (0.44 to 2.09) 71 No effect can be inferred from available
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