Question
Question Posted 08/13/14:
Hi Mike,
Thanks for your clarification on 10 Aug 2014 to my question regarding concomitant use of cholinesterase inhibitors and/or memantine during ADNI studies.
To make sure I have the correct understanding, I would like to seek clarification on your reply:
1) I understand from you that ADNI allows initiation of AChEI and/or memantine post-baseline during the study. However, if a subject in ADNI initiates memantine or an AChEI that he/she has not previously received, wouldn't that be considered a change in standard of care for that patient and hence it is not allowed?
2) Or does ADNI identify a set of treatments for MCI and Alzheimer's disease (eg specific AChEIs and memantine) at the beginning of each ADNI study, and subjects are allowed to change dose or initiate any of these, but if a new standard of care (eg anti-amyloid therapy) is approved during the course of ADNI, subjects in ADNI are not allowed to receive this?
Thanks in advance for your help.
Hi Mike,
Thanks for your clarification on 10 Aug 2014 to my question regarding concomitant use of cholinesterase inhibitors and/or memantine during ADNI studies.
To make sure I have the correct understanding, I would like to seek clarification on your reply:
1) I understand from you that ADNI allows initiation of AChEI and/or memantine post-baseline during the study. However, if a subject in ADNI initiates memantine or an AChEI that he/she has not previously received, wouldn't that be considered a change in standard of care for that patient and hence it is not allowed?
2) Or does ADNI identify a set of treatments for MCI and Alzheimer's disease (eg specific AChEIs and memantine) at the beginning of each ADNI study, and subjects are allowed to change dose or initiate any of these, but if a new standard of care (eg anti-amyloid therapy) is approved during the course of ADNI, subjects in ADNI are not allowed to receive this?
Thanks in advance for your help.
Response posted 08/13/14 by michael weiner:
Concerning 1) You must understand that NO research project is allowed to prevent a human subject from obtaining standard of care treatment. No IRB would allow such a restriction. ADNI operates under the same rules that ALL research projects operate under. Therefore, once enrolled, an ADNI subject can be prescibed ANY medication by their physician and we have no control over that, and we do NOT drop patients because of the meds they are prescribed.
2) We dont identify any set of treatments. We simply require that at the onset of the study people are on "stable doses" of treatments which effect cognition. ADNI subjects cannot enter into a clinical trial of a disease modifying or cognition enhancing treatment, If they do that the are dropped from ADNI. But a clinical trial is not standard of care treatment. If a new standard of care (anti amyloid treatment) were to be available, we would have to figure out how to deal with that , but saddly we dont expect to have this problem anytime soon
Mike
2) We dont identify any set of treatments. We simply require that at the onset of the study people are on "stable doses" of treatments which effect cognition. ADNI subjects cannot enter into a clinical trial of a disease modifying or cognition enhancing treatment, If they do that the are dropped from ADNI. But a clinical trial is not standard of care treatment. If a new standard of care (anti amyloid treatment) were to be available, we would have to figure out how to deal with that , but saddly we dont expect to have this problem anytime soon
Mike
