Question
Question Posted 08/05/14:
Dear ADNI team,
I am looking for information within the ADNI studies on the concomitant use of cholinesterase inhibitors, memantine and other treatments for Alzheimer's Disease after study entry in the MCI and AD populations. I understand from the ADNI protocols that the use of cholinesterase inhibitors and memantine is allowed if stable within weeks of screening. My questions are:
1) Does ADNI allow changes in dose or initiation of cholinesterase/memantine post-baseline during the study?
2) If not, does ADNI collect information on changes in dose or initiation of cholinesterase/memantine post-baseline during the study that may be protocol violations? If this information is collected, in which dataset/variables would this information be captured?
Thanks in advance for your help.
Dear ADNI team,
I am looking for information within the ADNI studies on the concomitant use of cholinesterase inhibitors, memantine and other treatments for Alzheimer's Disease after study entry in the MCI and AD populations. I understand from the ADNI protocols that the use of cholinesterase inhibitors and memantine is allowed if stable within weeks of screening. My questions are:
1) Does ADNI allow changes in dose or initiation of cholinesterase/memantine post-baseline during the study?
2) If not, does ADNI collect information on changes in dose or initiation of cholinesterase/memantine post-baseline during the study that may be protocol violations? If this information is collected, in which dataset/variables would this information be captured?
Thanks in advance for your help.
Response posted 08/10/14 by Michael Weiner:
in answer to your question:
1) yes ADNI allows changes in dose or initiation. It is not allowed to change standard of care treatment in any research study
2) there is an attempt to collect the information because at each ADNI visit the subject is asked to provide their medications. HOwever, this relies on the subject to provide this information accurately. Unfortunately, ADNI is not set up to obtain medication information from the clinical record.
1) yes ADNI allows changes in dose or initiation. It is not allowed to change standard of care treatment in any research study
2) there is an attempt to collect the information because at each ADNI visit the subject is asked to provide their medications. HOwever, this relies on the subject to provide this information accurately. Unfortunately, ADNI is not set up to obtain medication information from the clinical record.
