Clinical trials in mild cognitive impairment:
lessons for the future

Jelic V, Kivipelto M, Winblad B.
Karolinska Institutet, Sweden.
J Neurol Neurosurg Psychiatry. 2005 Nov 23


Mild cognitive impairment (MCI) is an operational definition for a cognitive decline in individuals that have a greater risk of developing dementia. With an increasing awareness of the heterogeneity of its clinical presentation, course and outcomes, diagnostic criteria have been further refined by addition of several MCI subtypes. The amnestic form of MCI is of particular interest because these individuals most likely progress to AlzheimerÂ's disease (AD). Because of assumed pathophysiological relationship between MCI and AD, currently hypothesized therapeutical approaches in MCI are mainly based on treatment strategies for AD. Several long-term secondary prevention randomized clinical trials in, mainly, amnestic MCI population have been completed so far, encompassing agents with various mechanisms of action: all three on the market available acetylcholinesterase inhibitors (donepezil, rivastigmine, galantamine), antioxidants (vitamin E), antiinflammatories (rofecoxib), nootropics (piracetam). Design of clinical trials in MCI is influenced by study objectives and definition of primary end points: time to clinical diagnosis of dementia, and AD in particular, or symptom progression. The fact that none of the drugs previously shown to have clinical efficacy in AD trials as well as benefit in everyday practice have met the primary objectives of the respective trials, indicates that the clinical trial design in MCI have to be further developed with a special attention being paid to the selection of more homogeneous samples at entry, optimal treatment duration and multidimensional and reliable outcomes.

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