Status:
ACTIVE_NOT_RECRUITING
Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Parkinson Disease
Eligibility:
All Genders
65+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04497168
Start Date
April 1 2021
End Date
March 1 2026
Last Update
February 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48109