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Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Citalopram 20mg

Placebo

About this trial

This is an interventional prevention trial for Parkinson Disease focused on measuring Serotonin, Selective Serotonin Reuptake Inhibitor, Amyloid-beta

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with a Parkinson Disease (PD) diagnosis based on the United Kingdom Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria
Modified Hoehn and Yahr (HY) scores spanning 2.0 to 3.0
Age 65 years or greater

Exclusion Criteria:

Diagnosis of an atypical parkinsonian condition
Participants on neuroleptics and participants with a history of use of anti-depressants (including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), bupropion, St. John's Wort or other serotoninergic agents in the year preceding study enrollment
Evidence of a large artery stroke or mass lesion on brain imaging
Participants with a life threatening comorbid illness
Severe claustrophobia precluding PET imaging
Inability to participate in research procedures involving ionizing radiation
Pregnancy or breastfeeding
Participants with active depression as defined by a Geriatric Depression Scale score of >10 or on the basis of clinical diagnosis by the PI
Participants who report active suicidal ideation as defined by an affirmative answer to questions 1 and 2 on the C-SSRS
Participants with baseline HY scores <2.0 or ≥3.0
Participants with a QTc interval on baseline EKG >0.43 for men or >0.45 for women, and/or >0.44 for men and >0.46 for women when on study drug/placebo
Subjects taking certain contraindicated medications at baseline
Subjects unable to swallow pills
Subjects with a previous history of mania, ongoing hepatic impairment or epilepsy
Subjects with a known allergy to citalopram or escitalopram
Subjects with substantial cognitive impairment or dementia that would prevent them from providing informed consent
Subjects in another ongoing clinical trial
Subjects with treatment-naieve Parkinson disease

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Citalopram

Placebo

Arm Description

20mg daily

matching placebo pills

Outcomes

Primary Outcome Measures

Change in visuospatial cortex PiB distribution volume ratio (DVR)

PiB PET can assess the density of amyloid-beta plaques in the brain. This imaging method will be used to quantify the amount of change in amyloid-beta plaques levels--measured specifically within the visuospatial cortex--between month 0 and month 26.

Secondary Outcome Measures

Change in Benton Judgement of Line Orientation (JOLO) test score

This is a standardized test with 30 items that is specific for visual spatial cognition. The minimum score is 0, indicating low visual spatial cognition. The maximum score is 30, indicating high visual spatial cognition.

Change in Montreal Cognitive Assessment (MoCA) score

This scale evaluates different domains of cognition like attention, orientation, memory, language, visuoconstructional capacities, and lastly, executive functions. MoCA is a 30 point test with lower scores indicating impaired cognition. The maximum score is 30.

Full Information

NCT ID

NCT04497168

First Posted

July 29, 2020

Last Updated

February 13, 2023

Sponsor

University of Michigan

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04497168

Brief Title

Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease

Official Title

Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

September 2025 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This Parkinson disease (PD) trial will test whether 26 months of citalopram, compared to placebo, can alter the build-up of toxic amyloid-beta plaques in the visuospatial cortex of the brain linked to visuospatial cognitive impairment in PD.

Detailed Description

This study is a proof-of-concept Parkinson disease trial aimed at delaying visuospatial cognitive decline, an important component of Parkinson dementia. In Parkinson disease, low-range cortical Abeta plaque levels associate with serotonin terminal losses. Multicenter Parkinson disease observational findings show that selective serotonin reuptake inhibitors (SSRIs) associate with lower dementia conversion risk and different cerebrospinal fluid Abeta-42 levels. This study aims to test the hypothesis that citalopram use in Parkinson disease will reduce visuospatial cortex Abeta plaque accrual, leading to an amelioration of longitudinal visuospatial cognitive decline linked to Parkinsonian dementia. The study will test this hypothesis in a randomized placebo-controlled trial of citalopram 20mg daily over 26 months in Parkinson disease subjects (age ≥65) without depression (n=58).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Serotonin, Selective Serotonin Reuptake Inhibitor, Amyloid-beta

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Citalopram

Arm Type

Experimental

Arm Description

20mg daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

matching placebo pills

Intervention Type

Drug

Intervention Name(s)

Citalopram 20mg

Intervention Description

20mg daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

matching placebo pills

Primary Outcome Measure Information:

Title

Change in visuospatial cortex PiB distribution volume ratio (DVR)

Description

Time Frame

Baseline to month 26

Secondary Outcome Measure Information:

Title

Change in Benton Judgement of Line Orientation (JOLO) test score

Description

Time Frame

Baseline to month 26

Title

Change in Montreal Cognitive Assessment (MoCA) score

Description

Time Frame

Baseline to month 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with a Parkinson Disease (PD) diagnosis based on the United Kingdom Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria Modified Hoehn and Yahr (HY) scores spanning 2.0 to 3.0 Age 65 years or greater Exclusion Criteria: Diagnosis of an atypical parkinsonian condition Participants on neuroleptics and participants with a history of use of anti-depressants (including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), bupropion, St. John's Wort or other serotoninergic agents in the year preceding study enrollment Evidence of a large artery stroke or mass lesion on brain imaging Participants with a life threatening comorbid illness Severe claustrophobia precluding PET imaging Inability to participate in research procedures involving ionizing radiation Pregnancy or breastfeeding Participants with active depression as defined by a Geriatric Depression Scale score of >10 or on the basis of clinical diagnosis by the PI Participants who report active suicidal ideation as defined by an affirmative answer to questions 1 and 2 on the C-SSRS Participants with baseline HY scores <2.0 or ≥3.0 Participants with a QTc interval on baseline EKG >0.45 for men or >0.47 for women Subjects taking certain contraindicated medications at baseline Subjects unable to swallow pills Subjects with a previous history of mania, ongoing hepatic impairment or epilepsy Subjects with a known allergy to citalopram or escitalopram Subjects with substantial cognitive impairment or dementia that would prevent them from providing informed consent Subjects in another ongoing clinical trial Subjects with treatment-naieve Parkinson disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cate Lewis

Phone

734-232-1199

cathlewi@med.umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vikas Kotagal, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vikas Kotagal

Phone

734-647-4331

vikaskot@umich.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Participant data will be uploaded in a timely manner in the "openICPSR" Data Management Resource (DMR) of ICPSR (Inter-University Consortium for Political and Social Research). Biospecimens (DNA) will be banked in the NIA NCRAD biorepository. Uploaded datasets will be stripped of identifiers in order to prevent the possibility of identifying human subjects participants in this study from the publically available dataset.

IPD Sharing Time Frame

Consistent with NIA policies, the study team will ensure the dataset is shared by the occurrence of the earlier of the following two milestones: either the date of primary publication or within 9 months of lifting of the data lock.

IPD Sharing Access Criteria

Access to the coded dataset that is uploaded to openICPSR is available to any individual who applies to the openICPSR for data access. This process involves providing a brief description of the intended use of the data to be downloaded, a data use agreement and data security plan, and documentation of IRB approval or exemption.

IPD Sharing URL

https://www.openicpsr.org/openicpsr/

Learn more about this trial

Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease

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