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

2020H0375

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.

2021-09-01

2023-10-06

2023-10-06

Withdrawn

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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-10-11