Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease (NCT04497168) | Clinical Trial Compass
CompletedPhase 2
Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease
United States58 participantsStarted 2021-04-01
Plain-language 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.
Who can participate
Age range65 Years
SexALL
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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 …
What they're measuring
1
Change in visuospatial cortex PiB distribution volume ratio (DVR)