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Anti-Diabetic Medications

Anti-Diabetic Medications for Parkinson's Disease and Lewy Body Dementia

Phase 4
Recruiting
Led By Jessica Wilson, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Bleeding disorder, use of anticoagulants, thrombocytopenia, or severe anemia
Use of high dose steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to see if certain medications are safe and helpful for patients with Parkinson's disease and Lewy body dementia.

Who is the study for?
This trial is for individuals with Parkinson's disease or Lewy body dementia. Specific criteria for joining are not provided, but typically participants must meet certain health standards and may be required to have a specific stage of the diseases.
What is being tested?
The study is testing two types of diabetes medications, Sitagliptin (a DPP4 inhibitor) and Dapagliflozin (an SGLT2 inhibitor), against a placebo to see if they can help with neurological symptoms in Parkinson's disease and Lewy body dementia.
What are the potential side effects?
While side effects are not listed here, common ones for Sitagliptin include sore throat, upper respiratory infection, headache and diarrhea; for Dapagliflozin they might include genital infections, increased urination, and potential risk of dehydration.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bleeding disorder or I'm on blood thinners.
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I am currently taking high doses of steroids.
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I cannot take certain diabetes medications due to allergies, past swelling reactions, pancreatitis, gallbladder issues, or kidney problems.
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I use insulin or diabetes medication other than metformin.
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I am currently on chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks 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 Mini Mental State Examination
Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Secondary study objectives
Glucose
Standing blood pressure
Supine blood pressure

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Sitagliptin GroupExperimental Treatment1 Intervention
Subjects will receive sitagliptin for the approximately 4-week treatment period.
Group II: Dapagliflozin GroupExperimental Treatment1 Intervention
Subjects will receive dapagliflozin for the approximately 4-week treatment period.
Group III: Placebo GroupPlacebo Group1 Intervention
Subjects will receive placebo for the approximately 4-week treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sitagliptin
2011
Completed Phase 4
~10170
Dapagliflozin
2014
Completed Phase 4
~64440

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,337 Total Patients Enrolled
Jessica Wilson, MDPrincipal InvestigatorMayo Clinic
~2 spots leftby Dec 2024
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