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

NCT ID: NCT04901494

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-10-06

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.

Conditions

Mild Cognitive Impairment; Dementia; Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

SSRI for at least one year prior to the diagnosis of MCI

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

Intervention Type: DRUG

Selective serotonin reuptake inhibitor

SSRI at the time of diagnosis and treated with it for at least 6 months after 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

Intervention Type: DRUG

Selective serotonin reuptake inhibitor

Subjects without SSRI use

Subjects without SSRI use

No interventions assigned to this group

Interventions

SSRI

Selective serotonin reuptake inhibitor

Intervention Type: DRUG

Other Intervention Names

Selective serotonin reuptake inhibitor

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Maria Kataki, MD, PhD

Associate Professor of Clinical Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Kataki, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2020H0375

Identifier Type: -

Identifier Source: org_study_id