---
title: Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease
nct_id: NCT04497168
overall_status: COMPLETED
phase: PHASE2
sponsor: University of Michigan
study_type: INTERVENTIONAL
primary_condition: Parkinson Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04497168.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04497168"
ct_last_update_post_date: 2026-03-16
last_seen_at: "2026-05-12T06:03:31.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease

**NCT ID:** [NCT04497168](https://clinicaltrials.gov/study/NCT04497168)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 58
- **Lead Sponsor:** University of Michigan
- **Collaborators:** National Institute on Aging (NIA)
- **Conditions:** Parkinson Disease
- **Start Date:** 2021-04-01
- **Completion Date:** 2026-03-02
- **CT.gov Last Update:** 2026-03-16

## 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).

## Eligibility

- **Minimum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Citalopram** (EXPERIMENTAL) — 20mg daily
- **Placebo** (PLACEBO_COMPARATOR) — matching placebo pills

## Interventions

- **Citalopram 20mg** (DRUG) — 20mg daily
- **Placebo** (DRUG) — matching placebo pills

## Primary Outcomes

- **Change in visuospatial cortex PiB distribution volume ratio (DVR)** _(time frame: Baseline to month 26)_ — 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 Outcomes

- **Change in Benton Judgement of Line Orientation (JOLO) test score** _(time frame: Baseline to month 26)_
- **Change in Montreal Cognitive Assessment (MoCA) score** _(time frame: Baseline to month 26)_

## Locations (1)

- University of Michigan, Ann Arbor, Michigan, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of michigan|ann arbor|michigan|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04497168.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04497168*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*