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

NCT04901494 | Withdrawn

• 1 other identifier: 2020H0375
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Dementia; Alzheimer Disease

Keywords

SSRI

Outcome Measures

Primary Outcomes (2)

• SSRI rate of progression to dementia

  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.

  2010-2019

• SSRI and acetylcholinesterase inhibitor use progression to dementia

  2.To determine if SSRI use in combination with acetylcholinesterase inhibitor use will affect the rate of progression to dementia.

  2010-2019

Secondary Outcomes (1)

• Rate of conversion from MCI to dementia and the other factors

  2010-2019

Study Arms (3)

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

Drug: SSRI

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

Drug: SSRI

Subjects without SSRI use

Subjects without SSRI use

Interventions

SSRI DRUG

Selective serotonin reuptake inhibitor

Also known as: 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 for at least one year prior to the diagnosis of MCI

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who meet the inclusion/exclusion criteria at the time of the initial diagnosis will be included in the review.

You may qualify if:

• Age 55+
• Diagnosis of mild cognitive impairment.
• 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.
• A minimum of two annual follow up evaluations.

You may not qualify if:

• Patients with CNS infection or inflammation
• HIV
• Syphilis
• Patients with poorly controlled Epilepsy based on the opinion of the investigator.
• Patients with space occupying lesions of the brain (glioma, meningioma, brain metastasis).
• Patients with systemic inflammatory condition or cancer undergoing chemotherapy or on chronic immune modulatory treatments.
• Blind patients that were not able to complete a cognitive assessment.
• Patients with chronic pain who are on excluded pain medications.
• Patients with Attention Deficit Disorder that require the use of stimulant medications.
• Patients with Traumatic Brain Injury.
• Patients with Cerebral Aneurysm Rupture.
• Patients taking an excluded medication.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Officials

• Maria Kataki, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Neurology

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 25, 2021
• Study Start: September 1, 2021
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)