DOES AAMI CONSTITUTE A REAL DISEASE ENTITY - A PLACEBO-CONTROLLED DOUBLE-BLIND-STUDY WITH SABELUZOLE (R58-735) IN A PATIENT POPULATION WITH REAL MEMORY PROBLEMS

Sabeluzole was studied in patients complaining spontaneously about their memory. They were screened and only included if they fitted into the AAMI‐criteria and if, additionally, they were poor performers on a Selective Reminding Procedure (SRP). Fifty‐three patients (aged between 52 and 90 years) were thus treated in a double‐blind manner with either sabeluzole 10 mg b.i.d. or placebo for 2 months. No intergroup differences were seen for any of the tests used. In the sabeluzole group, however, the learning of new semantic entities, consisting of a noun and an accompanying adjective (U, Td) in a Cued Recall Task, increased significantly (P = 0.04). Additionally, a higher Word Fluency score was obtained after sabeluzole treatment (P = 0.002), an effect not present in the placebo group. Objective improvements were paralleled by subjective improvements, as measured on Visual Analogue Scales, in the sabeluzole‐treated patients. The study drug was very well tolerated and no serious adverse reactions were seen. However, AAMI, even with the more stringent criteria we used, does not seem to define a homogeneous study population, which reflects a clinical entity. Therefore, the use of AAMI‐criteria as a research tool is questionable. Copyright © 1990 Wiley‐Liss, Inc.