SSRI's and the Rate of Progression From MCI to Dementia

Withdrawn

• Conditions: Dementia; Alzheimer Disease; Mild Cognitive Impairment
• Interventions: Drug: SSRI

• Registration Number: NCT04901494
• Lead Sponsor: Ohio State University

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.

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.

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-25
• Study Start: 2021-09-01
• Status Verified: 2023-10
• Primary Completion: 2023-10-06
• Study Completion: 2023-10-06
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 55+
2. Diagnosis of mild cognitive impairment.
3. One year treatment with an SSRI prior to diagnosis of MCI or six months treatment after diagnosis of MCI for the intervention groups. No treatment with an SSRI prior to the diagnosis of MCI or after the diagnosis of MCI for the control group.
4. A minimum of two annual follow up evaluations.

Exclusion Criteria

1. Patients with CNS infection or inflammation
2. HIV
3. Syphilis
4. Patients with poorly controlled Epilepsy based on the opinion of the investigator.
5. Patients with space occupying lesions of the brain (glioma, meningioma, brain metastasis).
6. Patients with systemic inflammatory condition or cancer undergoing chemotherapy or on chronic immune modulatory treatments.
7. Blind patients that were not able to complete a cognitive assessment.
8. Patients with chronic pain who are on excluded pain medications.
9. Patients with Attention Deficit Disorder that require the use of stimulant medications.
10. Patients with Traumatic Brain Injury.
11. Patients with Cerebral Aneurysm Rupture.
12. Patients with chronic psychiatric conditions, unless in remission. Recurrent chronic psychiatric condition in relapse, chronic recurrent Major Depression in relapse, chronic recurrent bipolar disorder, chronic relapsing schizoaffective disorder and chronic recurrent anxiety disorder requiring chronic use of benzodiazepines are exclusionary.
13. Patients taking an excluded medication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SSRI for at least one year prior to the diagnosis of MCI	SSRI	subjects with an initial diagnosis of MCI who were treated with an SSRI for at least one year prior to the diagnosis of MCI
SSRI at the time of diagnosis and treated with it for at least 6 months after the diagnosis of MCI	SSRI	SSRI at the time of diagnosis and treated with it for at least 6 months after the diagnosis of MCI

Primary Outcome Measures

Name	Time	Method
SSRI rate of progression to dementia	2010-2019	1.To determine if subjects treated with an SSRI for at least one year prior to the diagnosis of MCI or at least 6 months after the diagnosis of MCI will (a) have a lower rate of progression to Alzheimer's disease dementia or (b) have a lower rate of progression to other dementia conditions (i.e. Lewy Body Dementia, Frontotemporal Dementia, Vascular Dementia, Normal Pressure Hydrocephalus, Parkinson Disease Dementia... etc) compared to subjects who are not treated with an SSRI.
SSRI and acetylcholinesterase inhibitor use progression to dementia	2010-2019	2.To determine if SSRI use in combination with acetylcholinesterase inhibitor use will affect the rate of progression to dementia.

Secondary Outcome Measures

Name	Time	Method
Rate of conversion from MCI to dementia and the other factors	2010-2019	1. To investigate correlations between the rate of conversion from MCI to dementia and other factors.

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States