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

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must be taking: DPP4 inhibitors, SGLT2 inhibitors

Must not be taking: Insulin, Anticoagulants, Chemotherapy, others

Disqualifiers: Renal impairment, Bleeding disorder, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia.

Research Team

Jessica Wilson, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I have Parkinson's or Lewy Body Dementia and my treatment hasn't changed in the last 3 months.

I have pre-diabetes or mild diabetes according to the American Diabetes Association.

Exclusion Criteria

I have a bleeding disorder or I'm on blood thinners.

I am currently taking high doses of steroids.

I cannot take certain diabetes medications due to allergies, past swelling reactions, pancreatitis, gallbladder issues, or kidney problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dapagliflozin, sitagliptin, or placebo for the treatment period

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dapagliflozin
• Sitagliptin

Trial Overview 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.

Participant Groups

Group I: Sitagliptin Group Experimental Treatment 1 Intervention

Subjects will receive sitagliptin for the approximately 4-week treatment period.

Group II: Dapagliflozin Group Experimental Treatment 1 Intervention

Subjects will receive dapagliflozin for the approximately 4-week treatment period.

Group III: Placebo Group Placebo Group 1 Intervention

Subjects will receive placebo for the approximately 4-week treatment period.

Dapagliflozin is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Forxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Approved in United States as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Approved in Canada as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+