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Carbidopa Monotherapy and Carbidopa-Levodopa for Parkinsonism (RES Trial)

Q: Are patients currently being actively enrolled in this ongoing medical study?

<p>The information provided on clinicaltrials.gov indicates that this trial is not currently seeking participants. The trial was first posted on January 1st, 2024 and last updated on January 12th, 2024. Although this specific study is not actively recruiting patients, there are other trials available for enrollment at the moment.</p>

Phase 1 & 2

Recruiting

Led By Chatkaew Pongmala, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

Age 60 or older (M/F)

Evidence of mild parkinsonian signs (including slow gait (<1m/s))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7-13 days after beginning supplement.

Awards & highlights

RES Trial Summary

This trial aims to understand why walking becomes slower and more difficult as we age, and how certain factors can help compensate for these issues. Currently, there are no effective treatments available for this. Researchers have

Who is the study for?

This trial is for older adults experiencing slower walking and potential parkinsonian signs. Participants should be interested in exploring how dopamine levels affect their mobility. Key eligibility details are not provided, so it's assumed that typical health requirements must be met to participate.Check my eligibility

What is being tested?

The study tests the effects of Carbidopa-Levodopa (a medication known to increase dopamine levels) on walking speed and automation in older adults, compared with a placebo. It's a double-blinded study, meaning neither participants nor researchers know who receives the real medication or placebo.See study design

What are the potential side effects?

While specific side effects are not listed for this trial, Carbidopa-Levodopa commonly causes nausea, dizziness upon standing, and movement abnormalities. Placebos typically have no active ingredients but can cause perceived side effects due to expectations.

RES Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 60 years old or older.

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I walk slowly due to mild Parkinson's symptoms.

RES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-13 days after beginning supplement.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7-13 days after beginning supplement.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-13 days after beginning supplement. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average Gait Speed

Secondary outcome measures

Mean of Number of Incorrect Responses on the Stroop Color Word Stepping Test

Parkinson's Disease (PD)-Cognitive Rating Scale score

RES Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Carbidopa Monotherapy and Carbidopa-LevodopaExperimental Treatment2 Interventions

Participants will begin by taking 25mg of Carbidopa monotherapy three times per day (TID) for 3 days. On day four, participants will begin taking 1 tablet of Carbidopa-Levodopa (25/100mg) TID in addition to the Carbidopa monotherapy. On day seven, participants will increase to 1.5 tablets of Carbidopa-Levodopa (25/100mg) TID while maintaining 25mg Carbidopa monotherapy TID. The intervention will end after ten days of supplementation.

Group II: PlaceboPlacebo Group2 Interventions

Participants will begin by taking a 25mg placebo tablet three times per day (TID) for 3 days. On day four, participants will begin taking a separate placebo tablet TID in addition to the original placebo. On day seven, participants will increase to 1.5 tablets of the second placebo TID while maintaining 25mg original placebo TID. The intervention will end after ten days of supplementation.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,098 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,845 Total Patients Enrolled

1 Trials studying Parkinsonism

3,500 Patients Enrolled for Parkinsonism

Chatkaew Pongmala, PhDPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

16 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being actively enrolled in this ongoing medical study?

"The information provided on clinicaltrials.gov indicates that this trial is not currently seeking participants. The trial was first posted on January 1st, 2024 and last updated on January 12th, 2024. Although this specific study is not actively recruiting patients, there are other trials available for enrollment at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Placebo-Controlled Arm

Chatkaew Pongmala 2024. "Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Placebo-Controlled Arm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06219915.