What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include SSRIs like citalopram, cholinesterase inhibitors, and dopaminergic therapies. SSRIs can cause side effects such as nausea, dizziness, and increased risk of fractures. Cholinesterase inhibitors, like rivastigmine and donepezil, may lead to worsened tremor, nausea, and vomiting. Dopaminergic therapies, including levodopa and dopamine agonists, can result in nausea, somnolence, dizziness, confusion, hallucinations, and orthostatic hypotension. These treatments aim to manage symptoms but come with potential side effects that need to be monitored.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, primarily focusing on managing motor symptoms. These include levodopa, dopamine agonists (e.g., pramipexole, ropinirole), MAO-B inhibitors (e.g., selegiline, rasagiline), and COMT inhibitors (e.g., entacapone). While SSRIs like citalopram are not typically used for motor symptoms, they are sometimes prescribed to manage depression in Parkinson's patients. The current trial is unique in exploring citalopram's potential to reduce amyloid-beta plaque formation, a novel approach not previously approved by the FDA for Parkinson's Disease.

What other types of research exist?

Promising alternatives to Citalopram for Parkinson's Disease patients in 2024 could include other SSRIs like fluvoxamine, which has shown efficacy in behavioral symptoms of neurodegenerative diseases, and second-generation antipsychotics such as aripiprazole or brexpiprazole, which are used for cognitive and behavioral symptoms in other conditions. Additionally, novel treatments targeting amyloid-beta plaques, such as specific antibodies or pharmacological agents under development for amyloidosis, may also be considered.

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Selective Serotonin Reuptake Inhibitor

Citalopram for Parkinson's Disease

Phase 2

Waitlist Available

Led By Vikas Kotagal, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with a Parkinson Disease (PD) diagnosis based on the United Kingdom Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria

Age 65 years or greater

Must not have

Subjects unable to swallow pills

Subjects with a previous history of mania, ongoing hepatic impairment or epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 26

Awards & highlights

Summary

This trial will test if taking citalopram for a long period can reduce harmful brain plaques in older adults with Parkinson's disease. The goal is to see if this can help prevent or slow down memory and thinking problems. The study involves patients aged 65 and older who do not have depression. Citalopram has been observed to improve motor performance in Parkinson's disease patients when combined with levodopa.

Who is the study for?

This trial is for people aged 65 or older with Parkinson's Disease, having specific disease severity scores (HY 2.0 to 3.0). They must not have used antidepressants in the past year, have no major brain damage on imaging, no life-threatening illnesses, and cannot be pregnant or breastfeeding.

What is being tested?

The study tests if Citalopram can slow down the build-up of harmful plaques in a part of the brain affecting vision-related cognition in Parkinson's patients over a period of 26 months compared to a placebo.

What are the potential side effects?

Citalopram may cause side effects like nausea, sleepiness, dry mouth, increased sweating, trembling and sexual problems. It might also affect heart rhythm or lead to emotional changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's Disease.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow pills.

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I have a history of mania, liver issues, or epilepsy.

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I do not have cognitive impairments that prevent me from understanding this study.

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I have a serious health condition besides cancer.

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I cannot undergo tests that involve radiation.

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I have been diagnosed with an atypical form of Parkinson's disease.

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I have Parkinson's disease and have not received any treatment for it.

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I am not on any medications that would interfere with the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in visuospatial cortex PiB distribution volume ratio (DVR)

Secondary study objectives

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

Change in Montreal Cognitive Assessment (MoCA) score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CitalopramExperimental Treatment1 Intervention

20mg daily

Group II: PlaceboPlacebo Group1 Intervention

matching placebo pills

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Citalopram 20mg

2018

N/A

~130

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) include dopamine agonists and levodopa, which work by replenishing or mimicking dopamine to improve motor symptoms. Selective serotonin reuptake inhibitors (SSRIs) like citalopram are being studied for their potential to reduce amyloid-beta plaque formation, which may help manage cognitive impairments associated with PD. Understanding these mechanisms is essential for effectively addressing both motor and non-motor symptoms in PD patients.

Polypharmacy in Parkinson's disease: risks and benefits with little evidence.Pharmacologic approaches to the treatment of Huntington's disease.Initial agonist treatment of Parkinson disease: a critique.