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Thursday, June 30, 2016
Neotroin as an Emerging Alzehimer's Disease Treatment
Do you have any information on the drug "neotrofin" which is now in clinical trials. My mother has been asked to participate in the study.
Secondly, do you have any suggestions for evaluating clinical trial methodologies and how does a lay person evaluate the risks and benefits of participating in a clinical trial.
The study site should be your best source of information on this agent, which is also known as AIT-082. In a highly competitive free marketplace, most companies publicize very little about their experimental agents until the testing is quite advanced or even complete.
Providing explicit descriptions of the methods of the study, as well as the risks and benefits is the legal and moral obligation of the investigator. All studies must be approved by an ethics committee (also known as an Institutional Review Board) which evaluates potential risks and benefits of any given experimental approach. Investigators are required to provide information on known risks and known potential benefits and have the patient and/or representative sign a `consent form` attesting to the description of the study methods, risks, and benefits. However, it is important to remember that if everything about the drug was known already, then it would not be in testing anymore. There is no quick or easy way of evaluating the methods of a study except to ask the investigator all of your questions until they are answered to your satisfaction.
There are some warning signs to look for that might suggest a poor match between the investigator`s skills, the agent being tested, and your best interests:
1) The investigator seems uninformed of the details of the disease being studied, the agent, or the study method.
2) You feel pressured to sign a consent form.
3) You are promised a good result.
4) The investigator seems hesitant to work with or communicate with your own doctors.
5) The investigator can`t describe how unforeseen emergencies will be handled by the study team.
David Geldmacher, MD
Formerly, Assistant Professor of Neurology
School of Medicine
Case Western Reserve University