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

Recruiting in Palo Alto (17 mi)

Overseen byJessica Wilson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Mayo Clinic

Prior Safety Data

Breakthrough Therapy

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.

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.

+5 more

Participant Groups

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.

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.

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

🇪🇺 Approved in European Union as Forxiga for: