Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-01 @ 3:27 AM
Study NCT ID:
NCT04901494
Status:
WITHDRAWN
Last Update Posted:
2023-10-11
First Post:
2021-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SSRI's and the Rate of Progression From MCI to Dementia
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
Impact of SSRIs on the Rate of Progression of Patients With Mild Cognitive Impairment to Alzheimer's Disease Dementia and Other Neurodegenerative Dementias, With or Without Concurrent Use of Acetylcholinesterase Inhibitors
Status:
WITHDRAWN
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI is leaving the institution.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is investigating if serotonin reuptake inhibitor (SSRI) use in Mild Cognitive Impairment (MCI) patients will lead to a lower rate of progression to dementia.
It's hypothesized that patients treated with an SSRI at the time of MCI diagnosis, without evidence of an active primary psychiatric condition other than neurocognitive disorder, will have a lower rate of progression to Alzheimer's disease dementia or to other types of dementia.
It's hypothesized that patients treated with an SSRI at the time of MCI diagnosis, without evidence of an active primary psychiatric condition other than neurocognitive disorder, will have a lower rate of progression to Alzheimer's disease dementia or to other types of dementia.
Detailed Description:
Whether SSRIs affect the progression of MCI to dementia is not well studied with longitudinal prospectively collected date. Any decrease in the incidence of the progression of MCI to Alzheimer's dementia would be beneficial to patients.
This trial is investigating if serotonin reuptake inhibitor (SSRI) use in Mild Cognitive Impairment (MCI) patients will lead to a lower rate of progression to dementia.
This is a retrospective study of prospectively collected longitudinal data in patients followed at the Cognitive and Memory Disorders Center from 2010-2019. There are 3 arms: (1) subjects with an initial diagnosis of MCI who were treated with an SSRI for at least one year prior to the diagnosis of MCI (2) subjects with an initial diagnosis of MCI who were started on an SSRI at the time of diagnosis and treated with it for at least 6 months after the diagnosis of MCI and (3) subjects without SSRI use.
All the subjects have been evaluated based on a comprehensive standardized evaluation for the initial diagnosis and follow up over time. Chart reviews will be conducted on newly diagnosed MCI patients from 2010-2016 who have at least 2 years of annual follow up documented in their electronic medical record. Follow up visit notes through 2019 will be included in the review.
This trial is investigating if serotonin reuptake inhibitor (SSRI) use in Mild Cognitive Impairment (MCI) patients will lead to a lower rate of progression to dementia.
This is a retrospective study of prospectively collected longitudinal data in patients followed at the Cognitive and Memory Disorders Center from 2010-2019. There are 3 arms: (1) subjects with an initial diagnosis of MCI who were treated with an SSRI for at least one year prior to the diagnosis of MCI (2) subjects with an initial diagnosis of MCI who were started on an SSRI at the time of diagnosis and treated with it for at least 6 months after the diagnosis of MCI and (3) subjects without SSRI use.
All the subjects have been evaluated based on a comprehensive standardized evaluation for the initial diagnosis and follow up over time. Chart reviews will be conducted on newly diagnosed MCI patients from 2010-2016 who have at least 2 years of annual follow up documented in their electronic medical record. Follow up visit notes through 2019 will be included in the review.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: