Vellas_2007_J.Nutr.Health.Aging_11_313

One of the most difficult domains in Alzheimer's Therapeutic Trials is the definition of a good and clinically relevant end-point. We are please to present in this issue of the Journal the proceeding of the II International Task Force on Therapeutics Trials in Alzheimers disease devoted to outcomes. The meeting was held in Lisbon Portugal April 12 13 2007 and attracted participants at the top level from academic pharmaceutical research and regulatory agencies. C Sampaio underlines 1 the minimum clinically relevant parameters Minimal Clinical Important Change MCIC and Minimal Clinical Important Difference MCID. G Wilcok 2 summarises outcome for disease modifying trials Delaying the transition from one stage of the disease to another could be included in a time to event protocol. We learnt from J Durga 3 interesting data from the Facit Trial one example of a preventive trial looking at cognitive outcomes. The measurment of cognitive change in Alzheimer's disease clinical trials has been challenged by E Salmon 4 and JE Harrison 5 with some new data on the NTB neuropsychological test battery. Changes on the ADAS-Cog has been reported by F Cortes 6 and B Vellas 7 at 6 and 18 months in mild to moderate Alzheimer's patients treated with acetylcholinesterases inhibitors. The papers by F Verhey 8 P Robert 9 and G Frisoni 10 are foused respectively on caregivers neuropsychiatric and neuroimaging outcomes The costs of care for a patient with dementia is known to depend on a wide range of factors including the care setting presence of informal caregivers cognitive function ADL and instrumental ADL abilities behavioural disturbances and co-morbidities and this topic is elaborated by L Jonhson 11. Finally even if new disease-modifying drugs do become available in the near future they benefit may be outweighted by the benefits delivered by currently available symptomatic drugs Therefor a combination of potentially disease-modifying drugs with symptomatic drugs appears very likely Questions of reimbursement will be connected to differential benefit assessments between these classes of drugs. Thus careful assessment of outcomes of symptomatic drugs remains an issue of importance
1 C Sampaio Clinical Relevance on Alzheimer's Disease Endpoints J Nutr Health Aging 2007 11 4 316-317
2 G Wilcock Outcomes for Disease Modifying Trials J Nutr Health Aging 2007 11 4 318-319
3 J Durga et al What Can We Learn from the Facit Trial A Randomized Double Blind Controlled Trial J Nutr Health Aging 2007 11 4 320-324
4 E Salmon Outcome for secondary preventive trials in Mild Cognitive Impairment J Nutr Health Aging 2007 11 4 325-326
5 J.E Harrison Measuring Cognitive Change in Alzheimer's Disease Clinical Drug Trials J Nutr Health Aging 2007 11 4 327-329
6 F Cortes et al Six and 18-month Changes in Mild to Moderate Alzheimer's Patients Treated with Acetylcholinesterase Inhibitors What Can we Learn for Clinical Outcomes of Therapeutic trials J Nutr Health Aging 2007 11 4 330-337
7 B Vellas et al Long-Term Changes in ADAS-cog What Is Clinically Relevant for Disease Modifying Trials in Alzheimer J Nutr Health Aging 2007 11 4 338-341
8 F.R.J Verhey et al Caregiver outcomes in disease modifying trials J Nutr Health Aging 2007 11 4 342-344
9 P Robert et al Neuropsychiatric outcome for clinical trials J Nutr Health Aging 2007 11 4 345-347
10 G.B Frisoni et al Neuroimaging Outcomes for Clinical Trials J Nutr Health Aging 2007 11 4 348-352
11 L Jonsson Assessing health economic outcome in Alzheimer's disease clinical trials J Nutr Health Aging 2007 11 4 353-356
12 L Frolich Outcomes for Clinical Trials in Mild-to-Moderate Dementia to Evaluate Drugs with Presumably Symptomatic Effects J Nutr Health Aging 2007 11 4 357-358
13 S Lovestone et al Biomarkers for disease modification trials the Innovative Medicines Initiative and AddNeuroMed J Nutr Health Aging 2007 11 4 359-361.