Alzheimer's disease and public policy issues

1987 ◽  
Vol 2 (6) ◽  
pp. 33-37 ◽  
Author(s):  
T. Edwin Boling ◽  
Kathy M. Sommers
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Public Policy ◽  
Policy Issues

Regulatory Issues in Cognitive Enhancement Treatment Development

2017 ◽  
Author(s):  
Nicholas Kozauer ◽  
Karl Broich
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Cognitive Enhancement ◽  
Assessment Tools ◽  
Regulatory Agencies ◽  
Depression Treatment ◽  
Medicinal Products ◽  
Treatment Development ◽  
Policy Issues ◽  
Regulatory Issues

Improvement of cognition by medicinal products is an accepted concept by regulatory agencies. In dementing conditions such as Alzheimer’s disease, improvement of cognition or slowing its deterioration is essential for approval, particularly in early and mild to moderate stages of Alzheimer’s disease. In conditions such as schizophrenia or major depression, treatment of cognitive impairment is not considered as a pseudospecific indication, and specific clinical trials for such an indication are underway. Assessment tools for measurements of change in cognition and its relevance in functional or global outcome parameters must be validated in well-described patient populations. Developers are strongly encouraged to request scientific advice by regulatory agencies early in their programs to avoid delays or setbacks due to methodological or policy issues.

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