Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease

NCT04497168 | Completed Phase 2 FDA Drug

• 2 other identifiers: HUM001469051R01AG065246
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Serotonin; Selective Serotonin Reuptake Inhibitor; Amyloid-beta

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Benton Judgement of Line Orientation (JOLO) test score

  Baseline to month 26

• Change in Montreal Cognitive Assessment (MoCA) score

  Baseline to month 26

Study Arms (2)

Citalopram

EXPERIMENTAL

20mg daily

Drug: Citalopram 20mg

Placebo

PLACEBO COMPARATOR

matching placebo pills

Drug: Placebo

Interventions

Citalopram 20mg DRUG

20mg daily

Citalopram

Placebo DRUG

matching placebo pills

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Plaque, Amyloid

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vikas Kotagal, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 4, 2020
• Study Start: April 1, 2021
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Consistent with NIA policies, the study team will ensure the dataset is shared by the occurrence of the earlier of the following two milestones: either the date of primary publication or within 9 months of lifting of the data lock.
• Access Criteria: Access to the coded dataset that is uploaded to openICPSR is available to any individual who applies to the openICPSR for data access. This process involves providing a brief description of the intended use of the data to be downloaded, a data use agreement and data security plan, and documentation of IRB approval or exemption.

Locations

US (1)