Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04497168
• Other study ID #: HUM00146905
• Secondary ID: 1R01AG065246
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Citalopram 20mg
20mg daily
• Placebo
matching placebo pills

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to month 26
Secondary	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.	Baseline to month 26
Secondary	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.	Baseline to month 26