Allain H, Boyer P, Kossmann L, Lépine J P, Kanowski S
Faculté de Médecine de Rennes, France.
Pharmacopsychiatry. 1990 Feb;23 Suppl 2:49-51. doi: 10.1055/s-2007-1014532.
Uncertainty concerning therapeutic targets has probably retarded the development of cognition-enhancing drugs. While enhancement of normal cognitive function may be a legitimate goal it is unlikely that drugs developed without a clear clinical indication will ever be approved by regulatory authorities. Normal aging as a target would also appear to be excluded. The main debate is whether drugs should be developed for specific disease states (e.g., Alzheimer's), particular syndromes (e.g., AAMI) or for treating symptoms (e.g., memory deficits). Although targeting disease states appears the least problematic, it would be difficult to include many potentially treatable patients in such studies. In this respect, the status of AAMI is still the subject of much debate. In any case, it is important that trial populations be as homogeneous as possible, with clear diagnostic criteria (e.g., defined memory impairment, Hachinski score, CT scans) and that patients be moderately to severely affected.
治疗靶点的不确定性可能阻碍了认知增强药物的研发。虽然增强正常认知功能可能是一个合理的目标,但没有明确临床指征而研发的药物不太可能获得监管机构的批准。正常衰老作为一个靶点似乎也被排除在外。主要的争论在于药物是应该针对特定疾病状态(如阿尔茨海默病)、特定综合征(如急性失忆性认知障碍)还是治疗症状(如记忆缺陷)来研发。虽然针对疾病状态似乎问题最少,但在这类研究中很难纳入许多可能可治疗的患者。在这方面,急性失忆性认知障碍的情况仍然是诸多争论的主题。无论如何,重要的是试验人群应尽可能同质化,要有明确的诊断标准(如明确的记忆损害、哈金斯基评分、CT扫描),且患者应受到中度至重度影响。