Parkinson DiseasePhase 2NCT04497168
Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease
A Phase 2 study testing Citalopram 20mg in people with Parkinson Disease, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Citalopram 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 2 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Parkinson Disease
- Being tested
- Citalopram 20mg, Placebo
- Keywords
- Serotonin, Selective Serotonin Reuptake Inhibitor, Amyloid-beta
- Medical subject headings
- Parkinson Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram 20mgDrug
20mg daily
PlaceboDrug
matching placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Citalopram | Experimental | 20mg daily Receives: Drug: Citalopram 20mg |
| Placebo | Placebo comparator | matching placebo pills Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to month 26
Secondary outcomes (2)
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.
Measured: Baseline to month 26
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.
Measured: Baseline to month 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Apr 2021
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Vikas Kotagal, University of Michigan
- Investigators
- Vikas Kotagal, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497168
- Sponsor's protocol ID
- HUM00146905
- Other IDs
- 1R01AG065246
- Status last verified
- Jan 2026
- First submitted
- 29 Jul 2020
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease
- ClinicalTrials.gov ID
- NCT04497168
- Acronym / sponsor ID
- HUM00146905
- Conditions
- Parkinson Disease
- Keywords
- Serotonin, Selective Serotonin Reuptake Inhibitor, Amyloid-beta
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citalopram | Experimental | Drug: Citalopram 20mg20mg daily |
| Placebo | Placebo comparator | Drug: Placebomatching placebo pills |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citalopram 20mg20mg daily | Drug | Citalopram |
| Placebomatching placebo pills | Drug | Placebo |
Primary outcome
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.
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikas Kotagal, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Citalopram 20mg in people with Parkinson Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visuospatial cortex PiB distribution volume ratio (DVR) (time frame: Baseline to month 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.