Mild Cognitive ImpairmentNCT04901494
SSRI's and the Rate of Progression From MCI to Dementia
An observational study of Mild Cognitive Impairment and Dementia, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Dementia, Alzheimer Disease
- What is being tested?
- SSRI
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 6 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: Subjects who meet the inclusion/exclusion criteria at the time of the initial diagnosis will be included in the review.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 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.
- Patients taking an excluded medication.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- SSRI
- Keywords
- SSRI
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSRIDrug
Also called Selective serotonin reuptake inhibitor
Selective serotonin reuptake inhibitor
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: SSRI | |
| Subjects without SSRI use | Subjects without SSRI use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2010-2019
Secondary outcomes (1)
Rate of conversion from MCI to dementia and the other factors
- To investigate correlations between the rate of conversion from MCI to dementia and other factors.
Measured: 2010-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Sep 2021
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Why it stopped: The PI is leaving the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Kataki, MD, PhD, Ohio State University
- Investigators
- Maria Kataki, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901494
- Sponsor's protocol ID
- 2020H0375
- Status last verified
- Oct 2023
- First submitted
- 11 May 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04901494
- Acronym / sponsor ID
- 2020H0375
- Conditions
- Mild Cognitive Impairment, Dementia, Alzheimer Disease
- Keywords
- SSRI
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The PI is leaving the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SSRI for at least one year prior to the diagnosis of MCI | – | Drug: SSRIsubjects 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 | – | Drug: SSRISSRI at the time of diagnosis and treated with it for at least 6 months after the diagnosis of MCI |
| Subjects without SSRI use | – | –Subjects without SSRI use |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who meet the inclusion/exclusion criteria at the time of the initial diagnosis will be included in the review.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSRIAlso: Selective serotonin reuptake inhibitorSelective serotonin reuptake inhibitor | Drug | 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 |
Primary outcome
SSRI rate of progression to dementia
Time frame: 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
Time frame: 2010-2019
2.To determine if SSRI use in combination with acetylcholinesterase inhibitor use will affect the rate of progression to dementia.
1 secondary outcome
Rate of conversion from MCI to dementia and the other factors
Time frame: 2010-2019
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Kataki, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Dementia, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSRI rate of progression to dementia (time frame: 2010-2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.