Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105612
Status:
COMPLETED
Last Update Posted:
2009-12-29
First Post:
2005-03-15
Brief Title:
Memory Aid for Informed Consent in Alzheimers Research
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Improving Informed Consent in Alzheimers Disease Research
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to test whether a memory and organizational aid in the form of a document that summarizes and simplifies a studys key points can improve the decision-making abilities and competency of mild to early moderate Alzheimers disease AD patients
Detailed Description:
Studies of mild to moderate Alzheimers disease AD patients reveal substantial variation in their ability to participate in an informed consent process No published data show techniques that help an AD patient to participate in an informed consent This research will address this issue by performing a randomized trial to test whether a memory and organizational aid can improve the decision-making abilities and competency of AD patients
This study will recruit 80 patients with mild to early moderate AD and 30 non-demented elderly persons The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patients home The AD patients will be randomized to receive either the standard informed consent process or the intervention of the standard informed consent process plus the memory and organizational aid All non-demented elderly individuals will receive the standard informed consent process The interviewer will administer the protocol to participants and ask questions that will assess participant capacity to understand appreciate reason and make a choice concerning enrollment in the hypothetical study
This study will recruit 80 patients with mild to early moderate AD and 30 non-demented elderly persons The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patients home The AD patients will be randomized to receive either the standard informed consent process or the intervention of the standard informed consent process plus the memory and organizational aid All non-demented elderly individuals will receive the standard informed consent process The interviewer will administer the protocol to participants and ask questions that will assess participant capacity to understand appreciate reason and make a choice concerning enrollment in the hypothetical study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AG020627-01A2 | NIH | None | httpsreporternihgovquickSearch1R01AG020627-01A2 |